Trial Outcomes & Findings for Feasibility Trial of the Circumferential Abdominal Pelvic Pressure Device (CAPP) (NCT NCT01497756)

Results Overview

Number of patients on whom CAPP is used

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

Eight months

Results posted on

2020-02-26

Participant Flow

Participant milestones

Participant milestones
Measure	CAPP Application Patients in whom device is used
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility Trial of the Circumferential Abdominal Pelvic Pressure Device (CAPP)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CAPP Application n=10 Participants Patients in whom device is used
Age, Categorical <=18 years	NA Participants n=5 Participants
Age, Categorical Between 18 and 65 years	NA Participants n=5 Participants
Age, Categorical >=65 years	NA Participants n=5 Participants
Age, Continuous	NA years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Eight months

Population: Entire number of participants

Number of patients on whom CAPP is used

Outcome measures

Outcome measures
Measure	CAPP Application n=10 Participants Patients in whom device is used
Usage	10 participants

SECONDARY outcome

Timeframe: Eight months

Population: All patients

Any recorded complications

Outcome measures

Outcome measures
Measure	CAPP Application n=10 Participants Patients in whom device is used
Side Effects	0 participants

Adverse Events

CAPP Application

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

Mark Hauswald MD

uNewMexico

Phone: 505-269-6699

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place