Bariatric - Sleeve Gastrectomy Staple Line ReinforcementNCT03937011
Post-Market Clinical Follow-Up of STRATAFIX™ Spiral PDS™ PLUS
An observational study of Bariatric - Sleeve Gastrectomy Staple Line Reinforcement and Gynecology - Vaginal Cuff Closure, run by Ethicon, Inc. at 8 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric - Sleeve Gastrectomy Staple Line Reinforcement, Gynecology - Vaginal Cuff Closure
- What is being tested?
- Robotic Suturing of gastric sleeve oversew and vaginal cuff closure
- Type of treatment
- Medical device
- How many people
- 161 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 11 Dec 2019to 13 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects ≥ 18 years who are undergoing elective/non-emergent gastric or gynecological procedures robotically
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United States4 sites
Albany Medical
Albany, New York, 12208
Baptist Health South Florida
Miami, Florida, 33173
Mt. Sinai
New York, New York, 10029
Lenox Hill hospital
New York, New York, 10075
Germany2 sites
Universitaetsklinikum Hamburg Eppendorf
Hamburg
Klinuk fur Allgemelne, Viszeral-ThoraxTransplantations- und Kinderchirurgie
Kiel
About this study
Official title: 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.
- Conditions
- Bariatric - Sleeve Gastrectomy Staple Line Reinforcement, Gynecology - Vaginal Cuff Closure
- Being tested
- Robotic Suturing of gastric sleeve oversew and vaginal cuff closure
- Keywords
- STRATAFIX SPIRAL PDS PLUS, ROBOTIC SUTURING,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Suturing of gastric sleeve oversew and vaginal cuff closureDevice
- Robotic Bariatric Sleeve gastrectomy
- Robotic Hysterectomy with or without oophorectomy;
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Robotic Suturing of gastric sleeve oversew and vaginal cuff closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intra-op assessment (During Surgery; after suturing of the target tissue, Day of surgery)
Secondary outcomes (10)
Qualitative Assessment of Suture Handling
Suture breakage, correction suture used, reinforcement suture used, needle penetration, size, attachment; all rated 1-5
Measured: 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.
Measured: 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
Measured: Intra-op (during the surgery, Day of surgery)
Length of stay in hours
Time from admission to discharge
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Intra-op (during the surgery, Day of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start11 Dec 2019
- Primary completion10 May 2023
- Study completion13 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric - Sleeve Gastrectomy Staple Line ReinforcementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937011
- Sponsor's protocol ID
- ESC_2018_02
- Status last verified
- Feb 2026
- First submitted
- 26 Apr 2019
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Multispecialty Evaluation of STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices in Robotic Procedures
- ClinicalTrials.gov ID
- NCT03937011
- Acronym / sponsor ID
- ESC_2018_02
- Conditions
- Bariatric - Sleeve Gastrectomy Staple Line Reinforcement, Gynecology - Vaginal Cuff Closure
- Keywords
- STRATAFIX SPIRAL PDS PLUS, ROBOTIC SUTURING,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stratafix Arm | – | Device: Robotic Suturing of gastric sleeve oversew and vaginal cuff closureThe single study arm would comprise of two different specialties in Robotic surgical procedures: Bariatric Sleeve gastrectomy (Staple line reinforcement) and Hysterectomy (Vaginal cuff closure). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects ≥ 18 years who are undergoing elective/non-emergent gastric or gynecological procedures robotically
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic Suturing of gastric sleeve oversew and vaginal cuff closure1. Robotic Bariatric Sleeve gastrectomy 2. Robotic Hysterectomy with or without oophorectomy; | Device | Stratafix Arm |
Primary outcome
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.
10 secondary outcomes
Qualitative Assessment of Suture Handling
Time frame: Intra-op (at surgery, after suturing of the target tissue layer, Day of surgery)
Time to Closure (in minutes/seconds)
Time frame: Intra-op (during suturing of the target tissue, Day of surgery)
Overall procedure time (first incision to skin closure)
Time frame: Intra-op (during the surgery, Day of surgery)
Length of stay in hours
Time frame: Post-Operative up to 48 hrs
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)
Intra-operative leak test in bariatric procedure as per institutional standard of care, if any
Time frame: Intra-op (during Surgery; Day of surgery)
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)
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)
Abnormal vaginal discharge (total hysterectomy subjects)
Time frame: 14 days post-perative 90 days post-operative (+/- 30 days), 180 days post-operative (+/- 30 days)
C-SATS GEARS score
Time frame: Intra-op (during the surgery, Day of surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Yes. 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
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric - Sleeve Gastrectomy Staple Line Reinforcement and Gynecology - Vaginal Cuff Closure, run by Ethicon, Inc. at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.