NCT00894933 · REGISTRY CONDITION SEARCH

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: NA
Status at capture: COMPLETED
Registry last update: 2018-02-22

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.

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

Safety - Infection That Requires IV Antibiotics or Re-hospitalization

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outcome · POSTED

Successful Device Placement

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outcome · POSTED

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

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outcome · POSTED

Intraoperative/Postoperative Parameters - Estimated Blood Loss

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outcome · POSTED

Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts

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outcome · POSTED

Intraoperative/Postoperative Parameters - Total Device Placement Time

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outcome · POSTED

Intraoperative/Postoperative Parameters - Total Radical Prostatectomy Operative Time

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outcome · POSTED

Safety - Perforation of the Bowel or Bladder

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outcome · POSTED

Safety - Creation of a False Passage

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outcome · POSTED

Safety - Urinary Retention Requiring Catheterization Post-Device Removal

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outcome · POSTED

Safety - Mechanical Failure, Extrusion, Erosion, or Migration of the Device Requiring Surgical or Medical Intervention

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outcome · POSTED

Safety - Separation/Disruption of the Anastomosis Requiring Corrective Intervention

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outcome · POSTED

Safety - Bladder Neck Contracture

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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. * 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
healthy Volunteers: false
minimum Age: 40 Years
sex: MALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Verify the consistency of performance of the AMS CONTINUUM device in facilitating a sustainable anastomosis following a radical prostatectomy using updated Device design elements and Physician training materials on Device implant technique.
intervention Names
Device: CONTINUUM™
label
Continuum
type
EXPERIMENTAL

interventions

arm Group Labels
Continuum
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: 33
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.
measure
Safety - Infection That Requires IV Antibiotics or Re-hospitalization
time Frame
At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
description
Defined as the establishment of a water-tight anastomosis immediately post-Device placement.
measure
Successful Device Placement
time Frame
At Device placement
description
Evaluated by the proportion of Subjects who have had a successful Device placement and developed a functionally adequate anastomosis within 21 days post procedure (i.e. minimal or no extravasation noted during post-placement)
measure
Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-Device Placement in Subjects With Successful Device Placement
time Frame
7-21 days post-Device placement
description
Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.
measure
Safety - Perforation of the Bowel or Bladder
time Frame
At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
description
Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.
measure
Safety - Creation of a False Passage
time Frame
At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
description
Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.
measure
Safety - Urinary Retention Requiring Catheterization Post-Device Removal
time Frame
At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
description
Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.
measure
Safety - Mechanical Failure, Extrusion, Erosion, or Migration of the Device Requiring Surgical or Medical Intervention
time Frame
At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
description
Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.
measure
Safety - Separation/Disruption of the Anastomosis Requiring Corrective Intervention
time Frame
At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
description
Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.
measure
Safety - Bladder Neck Contracture
time Frame
At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal

secondary Outcomes

description
To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as blood loss.
measure
Intraoperative/Postoperative Parameters - Estimated Blood Loss
time Frame
At Device placement
measure
Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts
time Frame
7-10 and 13 - 15 days post-Device placement
description
To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as length of Device placement.
measure
Intraoperative/Postoperative Parameters - Total Device Placement Time
time Frame
At Device placement
description
To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as length of RP procedure.
measure
Intraoperative/Postoperative Parameters - Total Radical Prostatectomy Operative Time
time Frame
At Device placement

Full study description

brief 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.
detailed Description: Surgery is the main treatment for localized prostate cancer. The most common technique is a "radical prostatectomy," which involves removing the prostate gland, seminal vesicles and nearby lymph nodes. Radical prostatectomy is a major operation, most suitable for otherwise healthy men whose cancer does not appear to have spread.One of the most technically challenging aspects of this surgery is reconstruction of the interrupted urinary tract by hand suturing the bladder neck anastomosis, in which the bladder neck is sewn to the urethra after the prostate has been removed. CONTINUUM™ (study Device) is a surgical device intended to be used as part of the radical prostatectomy procedure. The Device facilitates approximation of the bladder neck and urethral stump by bringing together and holding the tissue in place until adequate natural healing of the vesico-urethral anastomosis occurs. CONTINUUM™ also approximates the bladder and urethral stump to minimize extravasation, while simultaneously providing a conduit for drainage of urine from the bladder while the anastomotic site heals. The concept of the CONTINUUM™ device and the feasibility of its operation have been 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 intent of this study is to verify CONTINUUM™ device performance across a variety of US sites and physicians using updated CONTINUUM™ device design modifications and physician training methodology on Device implant and removal techniques prior to initiation of a randomized US Pivotal study.

Source references

Source notices and limitations

Discovery and provenance

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exact text
NCT00894933
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query cond
Urethral Cancer
query disease state id
ds-urethral-cancer
source file
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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