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

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

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.

Study Overview

• Status: Completed
• Conditions: Bariatric - Sleeve Gastrectomy Staple Line Reinforcement; Gynecology - Vaginal Cuff Closure
• Intervention / Treatment: Device: Robotic Suturing of gastric sleeve oversew and vaginal cuff closure

• Study Type: Observational
• Enrollment (Actual): 161

Contacts and Locations

• Study Contact: Name: Christine Romanowski; Phone Number: 908-808-6219; Email: cromanow@its.jnj.com
• Study Contact Backup: Name: Jörg Tomaszewski, MD; Email: JTomasze@its.jnj.com

Study Locations

• Germany
  • Hamburg, Germany
    • Universitaetsklinikum Hamburg Eppendorf
  • Kiel, Germany
    • Klinuk fur Allgemelne, Viszeral-ThoraxTransplantations- und Kinderchirurgie
• Italy
  • Naples, Italy
    • University of Naples
  • Pisa, Italy
    • University Pisa
• United States
  • Florida
    • Miami, Florida, United States, 33173
      • Baptist Health South Florida
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical
    • New York, New York, United States, 10075
      • Lenox Hill Hospital
    • New York, New York, United States, 10029
      • Mt. Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Robotic Bariatric Sleeve gastrectomy; Robotic Hysterectomy with or without oophorectomy;

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Ethicon, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2019
• Primary Completion (Actual): May 10, 2023
• Study Completion (Actual): November 13, 2023

Study Registration Dates

• First Submitted: April 26, 2019
• First Submitted That Met QC Criteria: May 1, 2019
• First Posted (Actual): May 3, 2019

Study Record Updates

• Last Update Posted (Actual): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: STRATAFIX SPIRAL PDS PLUS, ROBOTIC SUTURING,
• Other Study ID Numbers: ESC_2018_02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No