Global Performance Evaluation of the AMS CONTINUUM™ Device
Global Performance Evaluation of the AMS CONTINUUM™ Device in Facilitating Vesico-Urethral Anastomosis Following a Radical Prostatectomy
- To evaluate Device performance in providing mucosa to mucosa apposition to facilitate sustainable vesico-urethral anastomosis during a radical prostatectomy procedure.
- To assess clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy.
Studieöversikt
Detaljerad beskrivning
Radical prostatectomy (RP) is the most utilized surgical treatment option for localized prostate cancer due to the multi-focal nature of the disease. RP is most suitable for otherwise healthy men whose cancer is limited to a small area. The RP procedure involves removing the prostate gland, seminal vesicles and nearby lymph nodes. One of the most technically challenging and critical aspects in all of these surgical approaches is reconstruction of the interrupted urinary tract by hand sewing the vesico-urethral anastomosis. This is where the bladder neck is sewn to the urethra after the prostate has been removed.
CONTINUUM™ (study Device) is to be used as part of the RP procedure by facilitating the approximation of the bladder neck and urethral stump. The Device brings together and holds the tissue in place until adequate natural healing of the vesico-urethral anastomosis occurs thereby minimizing extravasation. The Device also provides a conduit for drainage of urine from the bladder out the urethra during tissue healing.
The concept of the CONTINUUM™ device and the feasibility of its operation have been successfully tested in animal and human studies. Pilot clinical studies in the United States (G060095) found that the majority of subjects who received and were discharged with the Device demonstrated a water-tight vesico-urethral anastomosis at the first Device removal visit. Additionally, no unanticipated adverse device effects (UADEs) were reported. The focus of the proposed study is to further verify the performance of the Device in global research centers.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 4
Kontakter och platser
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: CONTINUUMTM
|
Prestanda hos CONTINUUM™ för att underlätta vesiko-urethral anastomos efter radikal prostatektomi.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Successful Device Placement
Tidsram: During Radical Prostatectomy
|
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
Tidsram: 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:
|
7-21 days post-Device placement
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Intraoperative/Postoperative Parameters
Tidsram: At Device placement
|
At Device placement
|
|
Percentage of Subjects Demonstrating Functionally Adequate Anastomosis at the 1st and 2nd Device Removal Visits
Tidsram: 7 and 14 days post-Device placement
|
7 and 14 days post-Device placement
|
|
Incontinence Rate and I-QOL Score
Tidsram: Baseline, 6-week, 6 and 12-month evaluations
|
Baseline, 6-week, 6 and 12-month evaluations
|
|
Bladder Neck Contracture (BNC) Rate
Tidsram: Subjects that develop BNC between the scheduled follow-up visits at 6 weeks, 6 and 12 months post-device removal
|
Subjects that develop BNC between the scheduled follow-up visits at 6 weeks, 6 and 12 months post-device removal
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Evangelos Liatsikos, MD, University of Patras
- Huvudutredare: Carlos Hernandez, MD, Hospital University Gregorio Maranon
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PE0702
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