Phase 4 N=10 Treatment

Global Performance Evaluation of the AMS CONTINUUM™ Device

Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01083199 ↗

Enrolled (actual)

Serious AEs

60.0%

Results posted

Apr 2016

Primary outcome: Primary: Successful Device Placement — 10 participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: CONTINUUM™ (Device)
Age: Adult, Older Adult · 40+ yrs
Sex: Male
Sponsor: American Medical Systems
Primary completion: Nov 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Successful Device Placement	10	—
PRIMARY Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-procedure in Subjects With Successful Device Placement	10	—
SECONDARY Intraoperative/Postoperative Parameters	—	—
SECONDARY Percentage of Subjects Demonstrating Functionally Adequate Anastomosis at the 1st and 2nd Device Removal Visits	—	—
SECONDARY Incontinence Rate and I-QOL Score	—	—
SECONDARY Bladder Neck Contracture (BNC) Rate	—	—

Summary

1. To evaluate Device performance in providing mucosa to mucosa apposition to facilitate sustainable vesico-urethral anastomosis during a radical prostatectomy procedure. 2. To assess clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy.

Eligibility Criteria

Inclusion Criteria

All males ≥ 40 years old who are indicated for a radical prostatectomy will be eligible to participate in the study

Exclusion Criteria

If contraindicated for surgery
Inability to understand the study or a history of non-compliance with medical advice
Unwilling or unable to sign an Informed Consent Form (ICF)
A history of:
Recurrent urinary tract infections (UTI)
Recurrent stricture disease
Neurological disease with a history of bladder dysfunction (e.g., Parkinson's disease)
Uncontrolled insulin-dependent diabetes
Chemotherapy within the past 6 months
Non-topical steroid use within the past 6 months
Allergy to nitinol, nickel, titanium or silicone

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01083199). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.