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

NCT03937011 | Completed FDA Device

• 1 other identifier: ESC_2018_02
• Study Type: observational
• Target: 161
• Locations: 3 countries
• Sites: 8

Brief 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.

Conditions

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

Keywords

STRATAFIX SPIRAL PDS PLUS, ROBOTIC SUTURING,

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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)

• Length of stay in hours

  Post-Operative up to 48 hrs

• 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)

Study Arms (1)

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).

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

Interventions

Robotic Suturing of gastric sleeve oversew and vaginal cuff closure DEVICE

1. Robotic Bariatric Sleeve gastrectomy 2. Robotic Hysterectomy with or without oophorectomy;

Stratafix Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects ≥ 18 years who are undergoing elective/non-emergent gastric or gynecological procedures robotically

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (8)

Baptist Health South Florida

Miami, Florida, 33173, United States

Location

Albany Medical

Albany, New York, 12208, United States

Location

Mt. Sinai

New York, New York, 10029, United States

Location

Lenox Hill hospital

New York, New York, 10075, United States

Location

Universitaetsklinikum Hamburg Eppendorf

Hamburg, Germany

Location

Klinuk fur Allgemelne, Viszeral-ThoraxTransplantations- und Kinderchirurgie

Kiel, Germany

Location

University of Naples

Naples, Italy

Location

University Pisa

Pisa, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: May 3, 2019
• Study Start: December 11, 2019
• Primary Completion: May 10, 2023
• Study Completion: November 13, 2023
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (4); IT (2); DE (2)