Trial Outcomes & Findings for Global Performance Evaluation of the AMS CONTINUUM™ Device (NCT NCT01083199)

Results Overview

Successful Device placement was defined as the establishment of a water-tight anastomosis immediately post-Device placement.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

During Radical Prostatectomy

Results posted on

2016-04-12

Participant Flow

Participant milestones

Participant milestones
Measure	AMS CONTINUUM™ Device
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Global Performance Evaluation of the AMS CONTINUUM™ Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AMS CONTINUUM™ Device n=10 Participants
Age, Continuous	64.7 Years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: During Radical Prostatectomy

Successful Device placement was defined as the establishment of a water-tight anastomosis immediately post-Device placement.

Outcome measures

Outcome measures
Measure	Continuum Device n=10 Participants
Successful Device Placement	10 participants

PRIMARY outcome

Timeframe: 7-21 days post-Device placement

Device removal was first attempted at the 7-day window; if extravasation was noted, the subject returned for a second attempt at the 14-day window. If extravasation was noted at the first and second attempts, the subject could then return for a 3rd and final removal at the 21-day window. The following defines the timeframe of each removal attempt: * 7-day window (7-10 days post-implant) * 14-day window (13-15 days post-implant) * 21-day window (19-21 days post-implant)

Outcome measures

Outcome measures
Measure	Continuum Device n=10 Participants
Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-procedure in Subjects With Successful Device Placement	10 participants with device removal by 21d

SECONDARY outcome

Timeframe: At Device placement

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 and 14 days post-Device placement

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6-week, 6 and 12-month evaluations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Subjects that develop BNC between the scheduled follow-up visits at 6 weeks, 6 and 12 months post-device removal

Outcome measures

Outcome data not reported

Adverse Events

AMS CONTINUUM™ Device

Serious events: 6 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AMS CONTINUUM™ Device n=10 participants at risk
Vascular disorders Hemorrhage	10.0% 1/10 • Number of events 1
Renal and urinary disorders Migration	10.0% 1/10 • Number of events 1
Renal and urinary disorders Separation/Distruption of Anastomosis	40.0% 4/10 • Number of events 4
Renal and urinary disorders Urinary Retention	10.0% 1/10 • Number of events 1
Renal and urinary disorders Urinary Tract Infection (UTI)	10.0% 1/10 • Number of events 1

Other adverse events

Other adverse events
Measure	AMS CONTINUUM™ Device n=10 participants at risk
Renal and urinary disorders False Passage	10.0% 1/10 • Number of events 1
Renal and urinary disorders Hematuria	50.0% 5/10 • Number of events 6
Renal and urinary disorders Rectal Injury	10.0% 1/10 • Number of events 1
Renal and urinary disorders Separation/Disruption of Anastomosis	40.0% 4/10 • Number of events 4

Additional Information

Laura Olson, Clinical Project Manager

American Medical Systems

Phone: 952-930-6428

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place