Trial Outcomes & Findings for Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage (NCT NCT02883673)

Last Updated: 2022-08-22

Results Overview

Control of postpartum hemorrhage, defined as the avoidance of non-surgical, second-line or surgical intervention to control uterine hemorrhage after the use of the Jada System per the Instructions for Use

Recruitment status

COMPLETED

Study phase

Target enrollment

107 participants

Primary outcome timeframe

24 hrs

Results posted on

2022-08-22

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Jada System for Postpartum Hemorrhage will be administered to subjects who are diagnosed with postpartum hemorrhage. Jada System: It is a teardrop-shaped, soft silicone ring that is placed into the uterus, where gentle suction is applied to cause the uterus to contract and shrink in size, compressing the blood vessels so the bleeding stops.
Overall Study STARTED	107
Overall Study COMPLETED	107
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Jada Arm n=107 Participants Treatment Arm
Age, Continuous	29.7 years STANDARD_DEVIATION 5.54 • n=5 Participants
Sex: Female, Male Female	107 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	88 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	26 Participants n=5 Participants
Race (NIH/OMB) White	61 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants
Region of Enrollment United States	107 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hrs

Population: Group of participants for whom Jada was activated

Outcome measures

Outcome measures
Measure	ITT Population n=106 Participants Group where Jada treatment was applied
Efficacy: Rate of Participants With Cessation of Uterine Hemorrhaging	100 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Participants in whom Jada was activated

Incidence (i.e., rate or number of participants), severity and seriousness of device-related Adverse Events experienced by participants will be documented during the course of the study.

Outcome measures

Outcome measures
Measure	ITT Population n=106 Participants Group where Jada treatment was applied
Safety: Incidence (i.e., Rate or Number of Participants), Severity and Seriousness of Device-related Adverse Events Experienced by Participants	8 Participants

Adverse Events

ITT Population

Serious events: 18 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ITT Population n=106 participants at risk Group where Jada treatment was applied
Infections and infestations Endometritis	2.8% 3/106 • Number of events 3 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Blood and lymphatic system disorders Anemia	2.8% 3/106 • Number of events 3 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Blood and lymphatic system disorders Anemia leading to hysterectomy	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Blood and lymphatic system disorders Anemia and tachycardia and hypotension	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Blood and lymphatic system disorders Continued bleeding due to undiscovered retained placenta	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Cardiac disorders Hypotension with complaint of dyspnea and nausea	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Cardiac disorders Pregnancy related hypertension	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Surgical and medical procedures C-section incision repair bleed	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Gastrointestinal disorders Constipation and hemorrhoid	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Skin and subcutaneous tissue disorders Laceration of cervix during difficult amniotomy	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Renal and urinary disorders Acute tubular necrosis	2.8% 3/106 • Number of events 3 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Respiratory, thoracic and mediastinal disorders Shortness of breath	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.

Other adverse events

Other adverse events
Measure	ITT Population n=106 participants at risk Group where Jada treatment was applied
Renal and urinary disorders acute tubular necrosis	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Blood and lymphatic system disorders Anemia	14.2% 15/106 • Number of events 15 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Blood and lymphatic system disorders Anemia with tachycardia	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Blood and lymphatic system disorders Lower uterine segment clot requiring removal	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Blood and lymphatic system disorders Passed clots at 4 weeks postpartum with pain	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Blood and lymphatic system disorders Pretibial edema	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Cardiac disorders Chest pain, SOB, diplopia, nausea without lab evidence of MI resolved without sequalae	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Cardiac disorders Pregnancy related hypertension	1.9% 2/106 • Number of events 2 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Skin and subcutaneous tissue disorders Cellulitis	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Skin and subcutaneous tissue disorders Cellulitis with yeast	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Skin and subcutaneous tissue disorders labial cyst	1.9% 2/106 • Number of events 2 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Skin and subcutaneous tissue disorders Leg rash associated with medication for hypertension	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Gastrointestinal disorders Constipation	1.9% 2/106 • Number of events 2 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Gastrointestinal disorders Dyspepsia	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Gastrointestinal disorders Hemorrhoid	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Infections and infestations Presumed endometritis	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Infections and infestations Presumed endometritis with pre-existing chorioamnionitis	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Infections and infestations upper respiratory tract influenza	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Infections and infestations Presumed endometritis with leukocytosis	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Infections and infestations bacterial vaginosis	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Infections and infestations Chlamydia	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Infections and infestations Endometritis	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Infections and infestations Mastitis	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Infections and infestations Uncomplicated urinary tract infection	1.9% 2/106 • Number of events 2 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Infections and infestations Vaginal yeast	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Nervous system disorders Migraine headache	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Nervous system disorders Spinal headache	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Skin and subcutaneous tissue disorders Vaginal pain and light bleeding from pre-existing laceration	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Skin and subcutaneous tissue disorders Breast rash	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Reproductive system and breast disorders Breast pain possibly blocked duct	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Renal and urinary disorders Dysuria	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Nervous system disorders Headache	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Reproductive system and breast disorders Pelvic and perineal pain	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Psychiatric disorders Anxiety	1.9% 2/106 • Number of events 2 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Psychiatric disorders Depression	1.9% 2/106 • Number of events 2 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Psychiatric disorders Depression, anxiety, PTSD	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Respiratory, thoracic and mediastinal disorders Shortness of breath	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
Skin and subcutaneous tissue disorders Disruption of laceration repair	0.94% 1/106 • Number of events 1 • Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days). Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort. One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.

Additional Information

Kathryn Wine, VP Clinical Operations

Alydia Health

Phone: 415-990-4104

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place