Post-Market Clinical Follow-Up of STRATAFIX™ Spiral PDS™ PLUS

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Multicenter, Multispecialty Evaluation of STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices in Robotic Procedures

Conditions
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Bariatric - Sleeve Gastrectomy Staple Line Reinforcement, Gynecology - Vaginal Cuff Closure

Intervention / Treatment
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* Device: Robotic Suturing of gastric sleeve oversew and vaginal cuff closure


Participation Criteria
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Eligibility Criteria
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Inclusion: 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 Exclusion: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stratafix Arm<br>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). | Device: Robotic Suturing of gastric sleeve oversew and vaginal cuff closure<br>* Robotic Bariatric Sleeve gastrectomy Robotic Hysterectomy with or without oophorectomy;<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | Intra-op assessment (During Surgery; after suturing of the target tissue, Day of surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative Assessment of Suture Handling | Suture breakage, correction suture used, reinforcement suture used, needle penetration, size, attachment; all rated 1-5 | Intra-op (at surgery, after suturing of the target tissue layer, Day of surgery) | 
| Time to Closure (in minutes/seconds) | The time to closure is defined as time in minutes and seconds between placement of the first suture throw in the target tissue to the completion of closure of that layer. The time in minutes and seconds will be captured as per operating room procedure. | Intra-op (during suturing of the target tissue, Day of surgery) | 
| Overall procedure time (first incision to skin closure) | Overall time is calculated as first incision to skin closure | Intra-op (during the surgery, Day of surgery) | 
| Length of stay in hours | Time from admission to discharge | Post-Operative up to 48 hrs | 
| Estimated intra-operative blood loss per institutional standard of care and incidence of subjects requiring blood transfusion | Blood loss calculated as per the standard of care of each institution | Intra-Op (during the surgery, Day of surgery) | 
| Intra-operative leak test in bariatric procedure as per institutional standard of care, if any | Leak test for sleeve gastrectomy patient as per institution standard | Intra-op (during Surgery; Day of surgery) | 
| Post-operative male/female dyspareunia related to sutures (total hysterectomy subjects) | Dyspareunia here is defined as painful sexual intercourse due to the sutures | 90 days post-operative (+/- 30 days), 180 days post-operative (+/- 30 days) | 
| Incisional site physical assessment:is suture palpable, suture line intact, or tender (all rated yes/no) | Incisional site will be assessed for hysterectomy subjects to see if the suture is palpable suture, tender or intact at the target site | 14 days post-perative 90 days post-operative (+/- 30 days), 180 days post-operative (+/- 30 days) | 
| Abnormal vaginal discharge (total hysterectomy subjects) | Hysterectomy patients will be assessed for any abnormal vaginal discharge if any. | 14 days post-perative 90 days post-operative (+/- 30 days), 180 days post-operative (+/- 30 days) | 
| C-SATS GEARS score | Global Evaluative Assessment of Robotic Skills (GEARS). Its a validated assessment tool for grading overall technical proficiency for robotic surgery. GEARS measures manual dexterity and fluidity of motion and does not define surgical or clinical judgement. The scales are Depth perception, Bimanual dexterity, efficiency, force sensitivity and robotic control.Each scale is scored 1 - 5, which means the total score could range from 5 - 25. | Intra-op (during the surgery, Day of surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STRATAFIX SPIRAL PDS PLUS, ROBOTIC SUTURING,