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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937011
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.

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 Intervention/treatment
Bariatric - Sleeve Gastrectomy Staple Line Reinforcement Gynecology - Vaginal Cuff Closure Device: Robotic Suturing of gastric sleeve oversew and vaginal cuff closure

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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 13, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

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




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937011


Contacts
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Contact: Giovanni Antonio Tommaselli, MD PhD gtommase@ITS.JNJ.com
Contact: Sanghita Bhattacharya, PhD sbhatt71@its.jnj.com

Locations
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United States, Florida
Baptist Health South Florida Recruiting
Miami, Florida, United States, 33173
United States, New York
Albany Medical Not yet recruiting
Albany, New York, United States, 12208
Mt. Sinai Recruiting
New York, New York, United States, 10029
Lenox Hill hospital Not yet recruiting
New York, New York, United States, 10075
Italy
University of Naples Not yet recruiting
Naples, Italy
Sponsors and Collaborators
Ethicon, Inc.
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Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT03937011    
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

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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
Keywords provided by Ethicon, Inc.:
STRATAFIX SPIRAL PDS PLUS, ROBOTIC SUTURING,