NCT02136121已完成1 期
Prospective Investigation of Robotic Single-port System
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- To determine the feasibility as measured by the rate of conversions
研究概览
简要总结
To determine the feasibility of representative urologic procedures as measured by the rate of conversions
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prostatectomy:
- •Patients age 18-75 years
- •BMI <=35 kg/m2
- •Confirmed localized adenocarcinoma of the prostate
- •Suitable for minimally invasive prostate cancer surgery
- •Nephrectomy:
- •Patient age 18-75 years
- •BMI <=35 kg/m2
- •Kidney disease amenable to nephrectomy or partial nephrectomy
- •Suitable for minimally invasive kidney surgery
排除标准
- •Untreated active infection (includes local kidney infection)
- •Vulnerable population (ex: prisoners, mentally disabled)
- •Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions (i.e., cancer)
- •Anatomy unsuitable for endoscopic visualization or minimally invasive surgery
- •Patient with second primary cancer
- •Extensive previous abdominal surgery
- •Prior radiation treatment for prostate or kidney cancer
- •Patient with distant metastasis
- •Complex renal vascular anatomy
- •Patient with kidney cancer - stage T3 or N+ M+ **
- •Horseshoe kidney**
- •Previous ipsilateral kidney surgery **- specific to kidney surgery -
结局指标
主要结局
To determine the feasibility as measured by the rate of conversions
时间窗: Intra Operative
Rate of Conversion to Open approach
次要结局
- Perioperative surgical outcomes(From admission to discharge from the hospital for the primary procedure typically up to 7 days)
- Perioperative Surgical outcomes(Intra-operative)
- Perioperative Surgical Outcomes(30 day, 1 year , 2 year and 3 year follow up)
- Post-operative - Continence(1 year, 2 year and 3 year follow up)
- Perioperative Surgical Outcome- potency(1 , 2 and 3 year follow up)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
A Novel Robotic System for Single Port and Natural Orifice Transluminal Endoscopic SurgeryUrologic NeoplasmsUrologic DiseasesNasopharyngeal NeoplasmsOropharyngeal NeoplasmsOral NeoplasmsHypopharyngeal NeoplasmsLaryngeal NeoplasmsENT DiseasesColorectal NeoplasmsNCT03010813Chinese University of Hong Kong63
招募中
不适用
Safety and Feasibility of Robotic SP Nipple Sparing MastectomyHigh Risk of Breast CancerBreast CancerNCT05245812Deborah Farr, MD90
招募中
不适用
Robot-assisted Urological Surgeries Using the MicroHand S RobotRenal CancerProstate CancerBladder CancerNCT05462392The Affiliated Hospital of Qingdao University136
招募中
不适用
Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused UltrasoundProstate AdenocarcinomaProstate CancerNCT05610852Case Comprehensive Cancer Center276
已完成
不适用
Robotic MIS With DexterHysterectomyPartial NephrectomyRight ColectomyNCT05537727Distalmotion SA100