Prostate Cancer
Conditions
Keywords
Prostate Cancer, Radical Prostatectomy, Vesico-Urethral Anastomosis
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.
Interventions
DEVICECONTINUUM™
Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy.
Sponsors
American Medical Systems
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Successful Device Placement | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts | 7-10 and 13 - 15 days post-Device placement | — |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Continuum Device Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Cancelled Procedure | 1 |
| Overall Study | Did not meeting incl/excl criteria | 1 |
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Continuum Device |
|---|---|
| Age, Continuous | 58.6 years STANDARD_DEVIATION 7.8 |
| Body Mass Index | 27.3 kg/m2 STANDARD_DEVIATION 3 |
| History of smoking | 19 Participants |
| Prostate size (g) via TRUS | 33.7 grams STANDARD_DEVIATION 7.9 |
| Region of Enrollment United States | 33 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 30 / 31 |
| serious Total, serious adverse events | 3 / 31 |
Outcome results
Primary
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)
Time frame: 7-21 days post-Device placement
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Continuum Device | Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-Device Placement in Subjects With Successful Device Placement | Successful removal at 21 days | 29 Participants |
| Continuum Device | Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-Device Placement in Subjects With Successful Device Placement | Device not effective | 1 Participants |
Primary
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.
Time frame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Population: Subjects in whom device placement was attempted
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Continuum Device | Safety - Bladder Neck Contracture | 6 Events |
Primary
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.
Time frame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Population: Subjects in whom device placement was attempted
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Continuum Device | Safety - Creation of a False Passage | 1 Events |
Primary
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.
Time frame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Population: Subjects in whom device placement was attempted
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Continuum Device | Safety - Infection That Requires IV Antibiotics or Re-hospitalization | 0 Events |
Primary
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.
Time frame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Population: Subjects in whom device placement was attempted
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Continuum Device | Safety - Mechanical Failure, Extrusion, Erosion, or Migration of the Device Requiring Surgical or Medical Intervention | 0 Events |
Primary
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.
Time frame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Population: Subjects in whom device placement was attempted
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Continuum Device | Safety - Perforation of the Bowel or Bladder | 1 Events |
Primary
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.
Time frame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Population: Subjects in whom device placement was attempted
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Continuum Device | Safety - Separation/Disruption of the Anastomosis Requiring Corrective Intervention | 1 Events |
Primary
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.
Time frame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Population: Subjects in whom device placement was attempted
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Continuum Device | Safety - Urinary Retention Requiring Catheterization Post-Device Removal | 0 Events |
Primary
Successful Device Placement
Defined as the establishment of a water-tight anastomosis immediately post-Device placement.
Time frame: At Device placement
Population: Subjects in whom device placement was attempted (i.e. treated subjects)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Continuum Device | Successful Device Placement | Successful | 30 Participants |
| Continuum Device | Successful Device Placement | Not successful | 1 Participants |
Secondary
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
Population: Subjects with successful device placement
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Continuum Device | Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts | Successful removal at 7 - 10 days | 24 Participants |
| Continuum Device | Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts | Successful removal at 21 day | 2 Participants |
| Continuum Device | Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts | Disrupted anastomosis requiring surgical intervent | 1 Participants |
| Continuum Device | Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts | Successful removal at 14 days | 3 Participants |
Secondary
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.
Time frame: At Device placement
Population: Subjects in whom device placement was attempted
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuum Device | Intraoperative/Postoperative Parameters - Estimated Blood Loss | 168.5 cc | Standard Deviation 219.6 |
Secondary
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.
Time frame: At Device placement
Population: Subjects in whom device placement was attempted
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuum Device | Intraoperative/Postoperative Parameters - Total Device Placement Time | 7.4 Minutes | Standard Deviation 5.6 |
Secondary
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.
Time frame: At Device placement
Population: Subjects in whom device placement was attempted
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuum Device | Intraoperative/Postoperative Parameters - Total Radical Prostatectomy Operative Time | 142.8 Minutes | Standard Deviation 34.3 |