A Prospective, Multicenter, Multispecialty Evaluation of STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices in Robotic Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 8
- 主要终点
- Percentage of subjects with no bleeding or mild bleeding (defined as success) at the completion of the suturing at the organ layer (vaginal cuff closure or gastric staple line reinforcement using STRATAFIX™ Spiral PDS™ Plus).
研究概览
简要总结
This single-arm, prospective, observational multicenter study will collect clinical data in a post-market setting across two different specialties in Robotic surgical procedures: Bariatric Sleeve gastrectomy (Staple line reinforcement) and Hysterectomy (Vaginal cuff closure). Investigators will perform the procedure using SFX Spiral PDS Plus in compliance with their standard surgical approach and the IFU.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elect to have a Robotic Bariatric Sleeve Gastrectomy or Robotic Total Hysterectomy where STRATAFIX™ Spiral PDS™ Plus device is used for staple line re-enforcement or vaginal cuff closure, respectively
- •Are willing and able to give consent and comply with all study-related evaluations and treatment scheduled
- •Subjects are ≥ 18 years of age
排除标准
- •Physical or psychological condition which would impair study participation or are unwilling or unable to participate in all required study visits
- •Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product
- •Enrolled in a concurrent clinical study (drug/device) that might affect current study primary or secondary endpoints
- •Allergic to poly (p-dioxanon), IRGACARE®* MP (triclosan) or D&C Violet No. 2 colorant
- •Pregnant or lactating female subjects as confirmed prior to the procedure
- •Subjects undergoing radical hysterectomy (Type B, C and D) according to Querleu & Morrow classification or gastric sleeve revision surgery
研究组 & 干预措施
Stratafix Arm
The single study arm would comprise of two different specialties in Robotic surgical procedures: Bariatric Sleeve gastrectomy (Staple line reinforcement) and Hysterectomy (Vaginal cuff closure).
干预措施: Robotic Suturing of gastric sleeve oversew and vaginal cuff closure (Device)
结局指标
主要结局
Percentage of subjects with no bleeding or mild bleeding (defined as success) at the completion of the suturing at the organ layer (vaginal cuff closure or gastric staple line reinforcement using STRATAFIX™ Spiral PDS™ Plus).
时间窗: Intra-op assessment (During Surgery; after suturing of the target tissue, Day of surgery)
The bleeding grade assessment used for the primary endpoint will be made right after the suturing is completed. Any re-bleeding after the initial assessment (just before the removal of the optics and trocars) from the suture line after this assessment will be considered a failure for the primary performance endpoint.
次要结局
- Qualitative Assessment of Suture Handling(Intra-op (at surgery, after suturing of the target tissue layer, Day of surgery))
- Time to Closure (in minutes/seconds)(Intra-op (during suturing of the target tissue, Day of surgery))
- Overall procedure time (first incision to skin closure)(Intra-op (during the surgery, Day of surgery))
- Estimated intra-operative blood loss per institutional standard of care and incidence of subjects requiring blood transfusion(Intra-Op (during the surgery, Day of surgery))
- Abnormal vaginal discharge (total hysterectomy subjects)(14 days post-perative 90 days post-operative (+/- 30 days), 180 days post-operative (+/- 30 days))
- C-SATS GEARS score(Intra-op (during the surgery, Day of surgery))
- Length of stay in hours(Post-Operative up to 48 hrs)
- Incisional site physical assessment:is suture palpable, suture line intact, or tender (all rated yes/no)(14 days post-perative 90 days post-operative (+/- 30 days), 180 days post-operative (+/- 30 days))
- Intra-operative leak test in bariatric procedure as per institutional standard of care, if any(Intra-op (during Surgery; Day of surgery))
- Post-operative male/female dyspareunia related to sutures (total hysterectomy subjects)(90 days post-operative (+/- 30 days), 180 days post-operative (+/- 30 days))