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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00894933 |
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Date of registration:
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05/05/2009 |
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Primary sponsor: |
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Public title:
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Performance Evaluation of the AMS CONTINUUM™ Device
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Scientific title:
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Performance Evaluation of the AMS CONTINUUM™ Device in Facilitating Vesico-Urethral Anastomosis Following a Radical Prostatectomy |
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Date of first enrolment:
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May 2009 |
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Target sample size:
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43 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00894933 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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John Libertino, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Lahey Clinic Medical Center |
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Name:
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Naveen Kella, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Urology San Antonio Research PA |
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Key inclusion & exclusion criteria
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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
Age minimum:
40 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Intervention(s)
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Device: CONTINUUM™
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Primary Outcome(s)
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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]
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Safety
[Time Frame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal]
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Successful Device placement
[Time Frame: At Device placement]
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Secondary Outcome(s)
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Intraoperative/Postoperative parameters
[Time Frame: At Device placement]
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Percentage of Subjects demonstrating functionally adequate anastomosis at the 1st and 2nd Device removal visits
[Time Frame: 7 and 14 days post-Device placement]
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Secondary ID(s)
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G090011
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PE0814
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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