Prostate CancerNCT00894933
Performance Evaluation of the AMS CONTINUUM™ Device
A study testing CONTINUUM™ in people with Prostate Cancer, run by American Medical Systems at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- CONTINUUM™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 6 sitesUnited States
- Study dates
- May 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Lahey Clinic Medical Center
Burlington, Massachusetts, 01805
Urology Clinics of North Texas
Dallas, Texas, 75231
Arkansas Urology
Little Rock, Arkansas, 72211
Urologic Consultants of Southeastern Pennsylvania
Philadelphia, Pennsylvania, 19004
Center for Urology
Rochester, New York, 14619
Urology San Antonio Research PA
San Antonio, Texas, 78205
About this study
Official title: Performance Evaluation of the AMS CONTINUUM™ Device in Facilitating Vesico-Urethral Anastomosis Following a Radical Prostatectomy
- To assess the safety of using the CONTINUUM™ device by monitoring the side effects and complications associated with the Device following a radical prostatectomy.
- To verify CONTINUUM™ device performance using updated CONTINUUM™ device design modifications, physician procedure guide and training methodology.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- CONTINUUM™
- Keywords
- Prostate Cancer, Radical Prostatectomy, Vesico-Urethral Anastomosis
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONTINUUM™Device
Also called Anastomosis Device
Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy.
| Study group | Role | What they receive |
|---|---|---|
| Continuum | Experimental | 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. Receives: Device: CONTINUUM™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Infection That Requires IV Antibiotics or Re-hospitalization
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.
Measured: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Successful Device Placement
Defined as the establishment of a water-tight anastomosis immediately post-Device placement.
Measured: At Device placement
Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-Device Placement in Subjects With Successful 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)
Measured: 7-21 days post-Device placement
Safety - Perforation of the Bowel or Bladder
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.
Measured: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Safety - Creation of a False Passage
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.
Measured: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Safety - Urinary Retention Requiring Catheterization 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.
Measured: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Safety - Mechanical Failure, Extrusion, Erosion, or Migration of the Device Requiring Surgical or Medical Intervention
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.
Measured: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Safety - Separation/Disruption of the Anastomosis Requiring Corrective Intervention
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.
Measured: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Safety - Bladder Neck Contracture
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.
Measured: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Secondary outcomes (4)
Intraoperative/Postoperative Parameters - Estimated Blood Loss
To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as blood loss.
Measured: At Device placement
Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts
Measured: 7-10 and 13 - 15 days post-Device placement
Intraoperative/Postoperative Parameters - Total Device Placement Time
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.
Measured: At Device placement
Intraoperative/Postoperative Parameters - Total Radical Prostatectomy Operative Time
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.
Measured: At Device placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Medical Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Naveen Kella, MD, Principal investigator, Urology San Antonio Research PAJohn Libertino, MD, Principal investigator, Lahey Clinic Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894933
- Sponsor's protocol ID
- PE0814
- Other IDs
- G090011
- Status last verified
- Jan 2017
- First submitted
- 5 May 2009
- Last updated
- 22 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of the AMS CONTINUUM™ Device in Facilitating Vesico-Urethral Anastomosis Following a Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT00894933
- Acronym / sponsor ID
- PE0814
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Radical Prostatectomy, Vesico-Urethral Anastomosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- American Medical SystemsIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 7 May 2009 (estimated)
- Results
- Posted 13 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To assess the safety of using the CONTINUUM™ device by monitoring the side effects and complications associated with the Device following a radical prostatectomy.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuum | Experimental | Device: 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CONTINUUM™Also: Anastomosis DevicePerformance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy. | Device | Continuum |
Primary outcome
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
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.
Successful Device Placement
Time frame: At Device placement
Defined as the establishment of a water-tight anastomosis immediately post-Device placement.
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
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)
Safety - Perforation of the Bowel or Bladder
Time frame: 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.
Safety - Creation of a False Passage
Time frame: 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.
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
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.
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
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.
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
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.
Safety - Bladder Neck Contracture
Time frame: 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.
4 secondary outcomes
Intraoperative/Postoperative Parameters - Estimated Blood Loss
Time frame: At Device placement
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
Intraoperative/Postoperative Parameters - Total Device Placement Time
Time frame: At Device placement
Intraoperative/Postoperative Parameters - Total Radical Prostatectomy Operative Time
Time frame: At Device placement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naveen Kella, MD principal investigator
Urology San Antonio Research PA
John Libertino, MD principal investigator
Lahey Clinic Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CONTINUUM™ in people with Prostate Cancer, run by American Medical Systems at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.