Performance Evaluation of the AMS CONTINUUM™ Device

• Sponsor: American Medical Systems (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00894933
• Collaborator: (none)
• Enrollment: 33
• Locations: 6
• Arm: 1
• Duration (Months): 19
• Patients Per Site: 5.5
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Device: CONTINUUM™	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Performance Evaluation of the AMS CONTINUUM™ Device in Facilitating Vesico-Urethral Anastomosis Following a Radical Prostatectomy
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Continuum 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.	Device: CONTINUUM™; Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy.; Other Names: Anastomosis Device

Outcome Measures

Primary Outcome Measures

1. Safety - Infection That Requires IV Antibiotics or Re-hospitalization [At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal]

   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.

2. Successful Device Placement [At Device placement]

   Defined as the establishment of a water-tight anastomosis immediately post-Device placement.

3. Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-Device Placement in Subjects With Successful Device Placement [7-21 days post-Device placement]

   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)

4. Safety - Perforation of the Bowel or Bladder [At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal]

   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.

5. Safety - Creation of a False Passage [At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal]

   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.

6. Safety - Urinary Retention Requiring Catheterization Post-Device Removal [At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal]

   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.

7. Safety - Mechanical Failure, Extrusion, Erosion, or Migration of the Device Requiring Surgical or Medical Intervention [At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal]

   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.

8. Safety - Separation/Disruption of the Anastomosis Requiring Corrective Intervention [At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal]

   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.

9. Safety - Bladder Neck Contracture [At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal]

   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.

Secondary Outcome Measures

1. Intraoperative/Postoperative Parameters - Estimated Blood Loss [At Device placement]

   To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as blood loss.

2. Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts [7-10 and 13 - 15 days post-Device placement]

3. Intraoperative/Postoperative Parameters - Total Device Placement Time [At Device placement]

   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.

4. Intraoperative/Postoperative Parameters - Total Radical Prostatectomy Operative Time [At Device placement]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arkansas Urology	Little Rock	Arkansas	United States	72211
2	Lahey Clinic Medical Center	Burlington	Massachusetts	United States	01805
3	Center for Urology	Rochester	New York	United States	14619
4	Urologic Consultants of Southeastern Pennsylvania	Philadelphia	Pennsylvania	United States	19004
5	Urology Clinics of North Texas	Dallas	Texas	United States	75231
6	Urology San Antonio Research PA	San Antonio	Texas	United States	78205

Sponsors and Collaborators

• American Medical Systems

Investigators

• Principal Investigator: Naveen Kella, MD, Urology San Antonio Research PA
• Principal Investigator: John Libertino, MD, Lahey Clinic Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: American Medical Systems
• ClinicalTrials.gov Identifier: NCT00894933
• Other Study ID Numbers: PE0814; G090011
• First Posted: May 7, 2009
• Last Update Posted: Feb 22, 2018
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by American Medical Systems: Prostate Cancer; Radical Prostatectomy; Vesico-Urethral Anastomosis
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Arm/Group Title	Continuum
Arm/Group 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. CONTINUUM™: Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy.
Period Title: Overall Study
STARTED	33
COMPLETED	29
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Continuum Device
Arm/Group Description	Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Overall Participants	33
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.6 (7.8)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	33 100%
Region of Enrollment (Count of Participants)
United States	33 100%
Body Mass Index (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	27.3 (3.0)
History of smoking (Count of Participants)
Count of Participants [Participants]	19 57.6%
Prostate size (g) via TRUS (grams) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [grams]	33.7 (7.9)

Outcome Measures

1. Primary Outcome

Title	Safety - Infection That Requires IV Antibiotics or Re-hospitalization
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.
Time Frame	At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal

Outcome Measure Data

Analysis Population Description

Subjects in whom device placement was attempted

Arm/Group Title	Continuum Device
Arm/Group Description	Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Measure Participants	31
Number [Events]	0

2. Primary Outcome

Title	Successful Device Placement
Description	Defined as the establishment of a water-tight anastomosis immediately post-Device placement.
Time Frame	At Device placement

Outcome Measure Data

Analysis Population Description

Subjects in whom device placement was attempted (i.e. treated subjects)

Arm/Group Title	Continuum Device
Arm/Group Description	Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Measure Participants	31
Successful	30 90.9%
Not successful	1 3%

3. Primary Outcome

Title	Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-Device Placement in Subjects With Successful 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)
Time Frame	7-21 days post-Device placement

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Continuum Device
Arm/Group Description	Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Measure Participants	30
Successful removal at 21 days	29 87.9%
Device not effective	1 3%

4. Secondary Outcome

Title	Intraoperative/Postoperative Parameters - Estimated Blood Loss
Description	To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as blood loss.
Time Frame	At Device placement

Outcome Measure Data

Analysis Population Description

Subjects in whom device placement was attempted

Arm/Group Title	Continuum Device
Arm/Group Description	Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Measure Participants	31
Mean (Standard Deviation) [cc]	168.5 (219.6)

5. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

Subjects with successful device placement

Arm/Group Title	Continuum Device
Arm/Group Description	Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Measure Participants	30
Successful removal at 7 - 10 days	24 72.7%
Successful removal at 14 days	3 9.1%
Successful removal at 21 day	2 6.1%
Disrupted anastomosis requiring surgical intervent	1 3%

6. Secondary Outcome

Title	Intraoperative/Postoperative Parameters - Total Device Placement Time
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.
Time Frame	At Device placement

Outcome Measure Data

Analysis Population Description

Subjects in whom device placement was attempted

Arm/Group Title	Continuum Device
Arm/Group Description	Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Measure Participants	31
Mean (Standard Deviation) [Minutes]	7.4 (5.6)

7. Secondary Outcome

Title	Intraoperative/Postoperative Parameters - Total Radical Prostatectomy Operative Time
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.
Time Frame	At Device placement

Outcome Measure Data

Analysis Population Description

Subjects in whom device placement was attempted

Arm/Group Title	Continuum Device
Arm/Group Description	Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Measure Participants	31
Mean (Standard Deviation) [Minutes]	142.8 (34.3)

8. Primary Outcome

Title	Safety - Perforation of the Bowel or Bladder
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.
Time Frame	At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal

Outcome Measure Data

Analysis Population Description

Subjects in whom device placement was attempted

Arm/Group Title	Continuum Device
Arm/Group Description	Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Measure Participants	31
Number [Events]	1

9. Primary Outcome

Title	Safety - Creation of a False Passage
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.
Time Frame	At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal

Outcome Measure Data

Analysis Population Description

Subjects in whom device placement was attempted

Arm/Group Title	Continuum Device
Arm/Group Description	Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Measure Participants	31
Number [Events]	1

10. Primary Outcome

Title	Safety - Urinary Retention Requiring Catheterization 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.
Time Frame	At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal

Outcome Measure Data

Analysis Population Description

Subjects in whom device placement was attempted

Arm/Group Title	Continuum Device
Arm/Group Description	Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Measure Participants	31
Number [Events]	0

11. Primary Outcome

Title	Safety - Mechanical Failure, Extrusion, Erosion, or Migration of the Device Requiring Surgical or Medical Intervention
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.
Time Frame	At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal

Outcome Measure Data

Analysis Population Description

Subjects in whom device placement was attempted

Arm/Group Title	Continuum Device
Arm/Group Description	Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Measure Participants	31
Number [Events]	0

12. Primary Outcome

Title	Safety - Separation/Disruption of the Anastomosis Requiring Corrective Intervention
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.
Time Frame	At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal

Outcome Measure Data

Analysis Population Description

Subjects in whom device placement was attempted

Arm/Group Title	Continuum Device
Arm/Group Description	Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Measure Participants	31
Number [Events]	1

13. Primary Outcome

Title	Safety - Bladder Neck Contracture
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.
Time Frame	At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal

Outcome Measure Data

Analysis Population Description

Subjects in whom device placement was attempted

Arm/Group Title	Continuum Device
Arm/Group Description	Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
Measure Participants	31
Number [Events]	6

Adverse Events

Time Frame	Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Arm/Group Title	Continuum Device
Arm/Group Description	Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
All Cause Mortality
	Continuum Device
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Continuum Device
	Affected / at Risk (%)	# Events
Total	3/31 (9.7%)
Cardiac disorders
Syncope	1/31 (3.2%)	1
Renal and urinary disorders
Bladder Neck Contracture/Outlet Obstruct	1/31 (3.2%)	1
Separation/Disruption of Anastomosis	1/31 (3.2%)	1
Surgical and medical procedures
Excessive bleeding	2/31 (6.5%)	2
Other (Not Including Serious) Adverse Events
	Continuum Device
	Affected / at Risk (%)	# Events
Total	30/31 (96.8%)
Cardiac disorders
Vasovagal Reaction	1/31 (3.2%)	1
Eye disorders
Tunnel Vision	1/31 (3.2%)	1
Gastrointestinal disorders
Pain/Discomfort - Abdominal	8/31 (25.8%)	8
Nausea	2/31 (6.5%)	2
Abdominal Bloating/Gas	1/31 (3.2%)	1
Constipation	1/31 (3.2%)	1
Loss of appetite	1/31 (3.2%)	1
General disorders
Pain/Discomfort	12/31 (38.7%)	12
Pain/Discomfort - Other	10/31 (32.3%)	13
Dizziness	1/31 (3.2%)	2
Hemorrhoid	1/31 (3.2%)	1
Light Headed	1/31 (3.2%)	1
Infections and infestations
Infection	3/31 (9.7%)	3
Urinary Tract Infection (UTI)	3/31 (9.7%)	3
Musculoskeletal and connective tissue disorders
Pain/Discomfort - Back	2/31 (6.5%)	2
Inguinal Hernia	1/31 (3.2%)	1
Renal and urinary disorders
Urinary Incontinence - De Novo	25/31 (80.6%)	26
Hematuria	6/31 (19.4%)	8
Urinary Retention	2/31 (6.5%)	2
Dysuria	1/31 (3.2%)	1
False Passage	1/31 (3.2%)	1
Perforation - Bladder	1/31 (3.2%)	1
Nocturia	2/31 (6.5%)	2
Bladder Spasm	1/31 (3.2%)	1
Clot in catheter	1/31 (3.2%)	1
Disease progession	1/31 (3.2%)	1
Increased Creatinine	1/31 (3.2%)	1
Kidney Stone	1/31 (3.2%)	1
Bladder Neck Contracture/Outlet Obstruct	5/31 (16.1%)	5
Reproductive system and breast disorders
Erectile Dysfunction - De Novo	18/31 (58.1%)	18
Erectile Dysfunction - Worsening	3/31 (9.7%)	3
Respiratory, thoracic and mediastinal disorders
Actelectasis	1/31 (3.2%)	1
Vascular disorders
Fluid Overload (Hypervolemia)	1/31 (3.2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.