CompletedNot Applicable

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

United States, Germany161 participantsStarted 2019-12-11

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

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).

Timeframe: Intra-op assessment (During Surgery; after suturing of the target tissue, Day of surgery)

Trial details

NCT IDNCT03937011

SponsorEthicon, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-05-10

View on ClinicalTrials.gov More Bariatric - Sleeve Gastrectomy Staple Line Reinforcement trials