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 : October 11, 2021
|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|
|Study Type :||Observational|
|Estimated Enrollment :||132 participants|
|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, 2022|
|Estimated Study Completion Date :||May 30, 2023|
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
- 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.
- 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
- 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.
- 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
- Length of stay in hours [ Time Frame: Post-Operative up to 48 hrs ]Time from admission to discharge
- 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
- 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
- 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
- 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
- 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.
- 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.
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
|Contact: Giovanni Antonio Tommaselli, MD PhD||+39 335 5717473||gtommase@ITS.JNJ.com|
|Contact: Christine Romanowskiemail@example.com|
|United States, Florida|
|Baptist Health South Florida||Recruiting|
|Miami, Florida, United States, 33173|
|United States, New York|
|Albany, New York, United States, 12208|
|New York, New York, United States, 10029|
|Lenox Hill hospital||Recruiting|
|New York, New York, United States, 10075|
|Universitaetsklinikum Hamburg Eppendorf||Not yet recruiting|
|Klinuk fur Allgemelne, Viszeral-ThoraxTransplantations- und Kinderchirurgie||Not yet recruiting|
|University of Naples||Recruiting|
|University Pisa||Not yet recruiting|