Performance Evaluation of the AMS CONTINUUM™ Device in Facilitating Vesico-Urethral Anastomosis Following a Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 12
- 主要终点
- Safety - Creation of a False Passage
研究概览
简要总结
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: CONTINUUM™ (Device)
结局指标
主要结局
Safety - Creation of a False Passage
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Intraoperative/Postoperative Parameters - Estimated Blood Loss(At Device placement)
- 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)
- Intraoperative/Postoperative Parameters - Total Radical Prostatectomy Operative Time(At Device placement)