Phase 4
Completed N=10
Global Performance Evaluation of the AMS CONTINUUM™ Device
Source: ClinicalTrials.gov NCT01083199 ↗Enrolled (actual)
10
Serious AEs
60.0%
Results posted
Apr 2016
Primary outcomePrimary: Successful Device Placement — 10 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 |
— | — |
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
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. Informational only — not medical advice.