Trial Outcomes & Findings for Connected Catheter - Safety and Effectiveness Study (NCT NCT04059159)

NCT ID: NCT04059159

Last Updated: 2023-01-20

Results Overview

Rate of participants treated with the Connected Catheter reported with a serious device related adverse event

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 8 participants
• Primary outcome timeframe: 0 - 49 days
• Results posted on: 2023-01-20

Participant Flow

Participant milestones

Measure	Connected Catheter Users Connected Catheter: Patients will use the Connected Catheter to empty the bladder during the course of treatment.
Overall Study STARTED	8
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Connected Catheter - Safety and Effectiveness Study

Baseline characteristics by cohort

Measure	Connected Catheter Users n=8 Participants Connected Catheter: Patients will use the Connected Catheter to empty the bladder during the course of treatment.
Age, Continuous	42.4 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	5 Participants n=5 Participants
Race/Ethnicity, Customized Other, Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants
Weight	166.8 lbs STANDARD_DEVIATION 33.3 • n=5 Participants
Ambulatory Status Fully Ambulatory	3 Participants n=5 Participants
Ambulatory Status Partially Ambulatory	2 Participants n=5 Participants
Ambulatory Status Non-Ambulatory	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0 - 49 days

Population: This is based on the number of patients who had catheter insertion attempted.

Rate of participants treated with the Connected Catheter reported with a serious device related adverse event

Outcome measures

Measure	Connected Catheter Users n=5 Participants Connected Catheter: Patients will use the Connected Catheter to empty the bladder during the course of treatment.
Number of Participants With Device Related Serious Adverse Events	0 Participants

SECONDARY outcome

Timeframe: 0 - 49 days

Population: This is based on the number of patients who had catheter insertion attempted.

Rate of participants treated with the Connected Catheter reported with a symptomatic urinary tract infection

Outcome measures

Measure	Connected Catheter Users n=5 Participants Connected Catheter: Patients will use the Connected Catheter to empty the bladder during the course of treatment.
Number of Participants With UTI (Occurrence Rate)	0 Participants

SECONDARY outcome

Timeframe: 0 - 40 days

Population: This is based on the number of patients who had catheter insertion attempted.

Rate of participants treated with the Connected Catheter that experience a lower urinary tract injury

Outcome measures

Measure	Connected Catheter Users n=5 Participants Connected Catheter: Patients will use the Connected Catheter to empty the bladder during the course of treatment.
Number of Participants With Lower Urinary Tract Injury	0 Participants

Adverse Events

Connected Catheter Users

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Derek Herrera

Spinal Singularity

Phone: 949-436-7974

Email: dherrera@urodevmedical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place