N/A
N=33
Performance Evaluation of the AMS CONTINUUM™ Device
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00894933 ↗Enrolled (actual)
33
Serious AEs
9.7%
Results posted
Mar 2017
Primary outcome: Primary: Safety - Infection That Requires IV Antibiotics or Re-hospitalization — 0 Events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CONTINUUM™ (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Male
- Sponsor
- American Medical Systems
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety - Infection That Requires IV Antibiotics or Re-hospitalization |
— | — |
| PRIMARY Successful Device Placement |
30; 1 | — |
| PRIMARY Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-Device Placement in Subjects With Successful Device Placement |
29; 1 | — |
| PRIMARY Safety - Perforation of the Bowel or Bladder |
1 | — |
| PRIMARY Safety - Creation of a False Passage |
1 | — |
| PRIMARY Safety - Urinary Retention Requiring Catheterization Post-Device Removal |
— | — |
| PRIMARY Safety - Mechanical Failure, Extrusion, Erosion, or Migration of the Device Requiring Surgical or Medical Intervention |
— | — |
| PRIMARY Safety - Separation/Disruption of the Anastomosis Requiring Corrective Intervention |
1 | — |
| PRIMARY Safety - Bladder Neck Contracture |
6 | — |
| SECONDARY Intraoperative/Postoperative Parameters - Estimated Blood Loss |
168.5 | — |
| SECONDARY Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts |
24; 3; 2; 1 | — |
| SECONDARY Intraoperative/Postoperative Parameters - Total Device Placement Time |
7.4 | — |
| SECONDARY Intraoperative/Postoperative Parameters - Total Radical Prostatectomy Operative Time |
142.8 | — |
Summary
1. To assess the safety of using the CONTINUUM™ device by monitoring the side effects and complications associated with the Device following a radical prostatectomy.
2. To verify CONTINUUM™ device performance using updated CONTINUUM™ device design modifications, physician procedure guide and training methodology.
Eligibility Criteria
Inclusion Criteria
- All males ≥ 40 years old who are indicated for a radical prostatectomy will be eligible to participate in the study.
- The Subject is willing and able to return for study follow-up visits according to the protocol.
- The Subject can be off diuretics and blood thinners for at least one week prior to surgery.
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)
- Participation in another clinical trial
- Previously implanted urological device
- A history of Recurrent urinary tract infections (UTI)
- A history of stricture disease
- Prior invasive prostate treatments (e.g., TURP, TUIP, laser therapy, radiotherapy, cryotherapy)
- 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
- History of connective tissue or autoimmune conditions
- Compromised immune system
- Allergy to nitinol, nickel, titanium or silicone
- Body Mass Index greater than or equal to 30
- American Society of Anesthesiologists Score of > 3
- Prostate size greater than or equal to 50 grams as determined by TRUS
Data sourced from ClinicalTrials.gov (NCT00894933). 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.