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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

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

Clinicaltrials.gov identifier NCT03937011

Recruitment Status Recruiting

First Posted May 3, 2019

Last update posted February 5, 2020

Study Description

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.

  • Condition or Disease:Bariatric - Sleeve Gastrectomy Staple Line Reinforcement
    Gynecology - Vaginal Cuff Closure
  • Intervention/Treatment: Device: Robotic Suturing of gastric sleeve oversew and vaginal cuff closure
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 132 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: A Prospective, Multicenter, Multispecialty Evaluation of STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices in Robotic Procedures
  • Actual Study Start Date: December 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: May 2021
Groups and Cohorts
Groups/Cohorts 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;
Outcome Measures
  • Primary Outcome Measures: 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). [ Time Frame: Intra-op assessment (During Surgery; after suturing of the target tissue, Day of surgery) ]
    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.
  • Secondary Outcome Measures: 1. Qualitative Assessment of Suture Handling [ Time Frame: Intra-op (at surgery, after suturing of the target tissue layer, Day of surgery) ]
    Suture breakage, correction suture used, reinforcement suture used, needle penetration, size, attachment; all rated 1-5
  • 2. Time to Closure (in minutes/seconds) [ Time Frame: Intra-op (during suturing of the target tissue, Day of surgery) ]
    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.
  • 3. Overall procedure time (first incision to skin closure) [ Time Frame: Intra-op (during the surgery, Day of surgery) ]
    Overall time is calculated as first incision to skin closure
  • 4. Length of stay in hours [ Time Frame: Post-Operative up to 48 hrs ]
    Time from admission to discharge
  • 5. Estimated intra-operative blood loss per institutional standard of care and incidence of subjects requiring blood transfusion [ Time Frame: Intra-Op (during the surgery, Day of surgery) ]
    Blood loss calculated as per the standard of care of each institution
  • 6. Intra-operative leak test in bariatric procedure as per institutional standard of care, if any [ Time Frame: Intra-op (during Surgery; Day of surgery) ]
    Leak test for sleeve gastrectomy patient as per institution standard
  • 7. Post-operative male/female dyspareunia related to sutures (total hysterectomy subjects) [ Time Frame: 90 days post-operative (+/- 30 days), 180 days post-operative (+/- 30 days) ]
    Dyspareunia here is defined as painful sexual intercourse due to the sutures
  • 8. Incisional site physical assessment:is suture palpable, suture line intact, or tender (all rated yes/no) [ Time Frame: 14 days post-perative 90 days post-operative (+/- 30 days), 180 days post-operative (+/- 30 days) ]
    Incisional site will be assessed for hysterectomy subjects to see if the suture is palpable suture, tender or intact at the target site
  • 9. Abnormal vaginal discharge (total hysterectomy subjects) [ Time Frame: 14 days post-perative 90 days post-operative (+/- 30 days), 180 days post-operative (+/- 30 days) ]
    Hysterectomy patients will be assessed for any abnormal vaginal discharge if any.
  • 10. C-SATS GEARS score [ Time Frame: Intra-op (during the surgery, Day of surgery) ]
    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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Probability Sample
  • Study Population: Subjects ≥ 18 years who are undergoing elective/non-emergent gastric or gynecological procedures robotically
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

Contacts and Locations
Contacts

Contact: Giovanni Antonio Tommaselli, MD PhD gtommase@ITS.JNJ.com

Contact: Sanghita Bhattacharya, PhD sbhatt71@its.jnj.com

Locations

United States, Florida
Baptist Health South Florida
Miami

United States, New York
Albany Medical
Albany

United States, New York
Mt. Sinai
New York

United States, New York
Lenox Hill hospital
New York

Italy
University of Naples
Naples

Sponsors and Collaborators

Ethicon, Inc.

More Information
  • Responsible Party: Ethicon, Inc.
  • ClinicalTrials.gov Identifier: NCT03937011 History of Changes
  • Other Study ID Numbers: ESC_2018_02
  • First Posted: May 3, 2019 Key Record Dates
  • Last Update Posted: February 5, 2020
  • Last Verified: January 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • 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
  • URL: http://yoda.yale.edu
  • 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.: Yes
  • Keywords provided by Ethicon, Inc.: STRATAFIX SPIRAL PDS PLUS, ROBOTIC SUTURING,