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New stitch tool tested in robot surgeries shows promise

NCT ID NCT03937011

Knowledge-focused Sponsor: Ethicon, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a special stitch device (STRATAFIX Spiral PDS Plus) used in robot-assisted surgeries for weight loss (sleeve gastrectomy) and hysterectomy. 161 adults took part. The main goal was to see how well it controlled bleeding after stitching. Doctors also rated how easy it was to use. The study was completed and provides information on the device's performance in real-world settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

161 people

The number who actually took part.

Started

Dec 2019

Finished

Nov 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

obesity disorder uterine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bariatric - sleeve gastrectomy staple line reinforcement Gynecology - vaginal cuff closure

Contacts and locations

Locations

  • Albany Medical

    Albany, New York, 12208, United States

  • Baptist Health South Florida

    Miami, Florida, 33173, United States

  • Klinuk fur Allgemelne, Viszeral-ThoraxTransplantations- und Kinderchirurgie

    Kiel, Germany

  • Lenox Hill hospital

    New York, New York, 10075, United States

  • Mt. Sinai

    New York, New York, 10029, United States

  • Universitaetsklinikum Hamburg Eppendorf

    Hamburg, Germany

  • University Pisa

    Pisa, Italy

  • University of Naples

    Naples, Italy

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