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

Ethicon

Status: Completed

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

Treatments: Device: Robotic Suturing of gastric sleeve oversew and vaginal cuff closure

Study type: Observational

Funder types: Industry

Identifiers

NCT03937011

ESC_2018_02

Details and patient eligibility

About

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.

Enrollment: 161 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

1. 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
2. Are willing and able to give consent and comply with all study-related evaluations and treatment scheduled
3. Subjects are ≥ 18 years of age

Exclusion:

1. Physical or psychological condition which would impair study participation or are unwilling or unable to participate in all required study visits
2. Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product
3. Enrolled in a concurrent clinical study (drug/device) that might affect current study primary or secondary endpoints
4. Allergic to poly (p-dioxanon), IRGACARE®* MP (triclosan) or D&C Violet No. 2 colorant
5. Pregnant or lactating female subjects as confirmed prior to the procedure
6. Subjects undergoing radical hysterectomy (Type B, C and D) according to Querleu & Morrow classification or gastric sleeve revision surgery

Trial design

161 participants in 1 patient group

Stratafix Arm

Description:

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).

Treatment:

Device: Robotic Suturing of gastric sleeve oversew and vaginal cuff closure