Global Performance Evaluation of the AMS CONTINUUM™ Device

NCT01083199 | Completed Phase 4 Results

• 1 other identifier: PE0702
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Radical Prostatectomy; Vesico-Urethral Anastomosis

Outcome Measures

Primary Outcomes (2)

• Successful Device Placement

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

  During Radical Prostatectomy

• Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-procedure in Subjects With Successful 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)

  7-21 days post-Device placement

Secondary Outcomes (4)

• Intraoperative/Postoperative Parameters

  At Device placement

• Percentage of Subjects Demonstrating Functionally Adequate Anastomosis at the 1st and 2nd Device Removal Visits

  7 and 14 days post-Device placement

• Incontinence Rate and I-QOL Score

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

• Bladder Neck Contracture (BNC) Rate

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

Study Arms (1)

CONTINUUMTM

EXPERIMENTAL

Device: CONTINUUM™

Interventions

CONTINUUM™ DEVICE

Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy.

Also known as: Anastomosis Device

CONTINUUMTM

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• American Medical Systems: lead

Study Sites (2)

University of Patras

Rio-Patras, 26500, Greece

Location

Hospital University Gregorio Maranon

Madrid, 28007, Spain

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Continuity of Patient Care

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Laura Olson, Clinical Project Manager
• Organization: American Medical Systems

laura.olson2@bsci.com

952-930-6428

Study Officials

• Evangelos Liatsikos, MD

  University of Patras

  PRINCIPAL INVESTIGATOR

• Carlos Hernandez, MD

  Hospital University Gregorio Maranon

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: March 9, 2010
• Study Start: October 1, 2007
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: April 12, 2016
• Results First Posted: April 12, 2016

Record last verified: 2011-06

Locations

GR (1); ES (1)