NCT01083199 · REGISTRY CONDITION SEARCH

Global Performance Evaluation of the AMS CONTINUUM™ Device

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE4
Status at capture: COMPLETED
Registry last update: 2016-04-12

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Successful Device Placement

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outcome · POSTED

Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-procedure in Subjects With Successful Device Placement

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outcome · NOT POSTED

Intraoperative/Postoperative Parameters

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outcome · NOT POSTED

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

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outcome · NOT POSTED

Incontinence Rate and I-QOL Score

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outcome · NOT POSTED

Bladder Neck Contracture (BNC) Rate

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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: 1. Recurrent urinary tract infections (UTI) 2. 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
healthy Volunteers: false
minimum Age: 40 Years
sex: MALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Device: CONTINUUM™
label
CONTINUUMTM
type
EXPERIMENTAL

interventions

arm Group Labels
CONTINUUMTM
description
Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy.
name
CONTINUUM™
other Names
Anastomosis Device
type
DEVICE

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 10
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Successful Device placement was defined as the establishment of a water-tight anastomosis immediately post-Device placement.
measure
Successful Device Placement
time Frame
During Radical Prostatectomy
description
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)
measure
Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-procedure in Subjects With Successful Device Placement
time Frame
7-21 days post-Device placement

secondary Outcomes

measure
Intraoperative/Postoperative Parameters
time Frame
At Device placement
measure
Percentage of Subjects Demonstrating Functionally Adequate Anastomosis at the 1st and 2nd Device Removal Visits
time Frame
7 and 14 days post-Device placement
measure
Incontinence Rate and I-QOL Score
time Frame
Baseline, 6-week, 6 and 12-month evaluations
measure
Bladder Neck Contracture (BNC) Rate
time Frame
Subjects that develop BNC between the scheduled follow-up visits at 6 weeks, 6 and 12 months post-device removal

Full study description

brief 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.
detailed Description: 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.

Source references

Source notices and limitations

Discovery and provenance

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ctgov-registry-1336d216cbd1bbff780dac70
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occurrences
context exact
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end
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exact text
NCT01083199
start
0
offset unit
unicode_code_points
query cond
Urethral Cancer
query disease state id
ds-urethral-cancer
source file
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source file sha256
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source json pointer
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source kind
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source record id
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source string basis
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source string sha256
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Urethral+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice