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New stitch device aims to make hysterectomy recovery safer

NCT ID NCT05570916

Disease control Sponsor: ZSX Medical LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 device called Zip-Stitch® that helps close the vaginal cuff during minimally invasive hysterectomy. Researchers wanted to see if it was safe and worked well by checking how often the implant came out on its own and how well the wound healed. 23 women took part, and their results were compared to a reference group.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

23 people

The number who actually took part.

Started

Aug 2023

Finished

May 2025

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.

Ages

18 years and older

Sex

Female participants only

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 Criteria: 1\. Provision of signed and dated Informed Consent Form 2. Stated willingness to comply with all study procedures, including participation in follow-up visits and telephonic follow-up 3. Female 18 years and older 5. Indicated for Laparoscopic Hysterectomy (includes Total Laparoscopic Hysterectomy, Laparoscopic Assisted Vaginal Hysterectomy, or robotic assisted vaginal hysterectomy) Exclusion Criteria: 1. History of Human Immunodeficiency Virus (HIV) 2. History of Hepatitis C 3. History of diabetes that, in the opinion of the investigator, may delay healing 4. Current use of systemic corticosteroids 5. Active infection of genitals, vagina, cervix, uterus or urinary tract 6. Active bacteremia, sepsis or other active systemic infection 7. Presence of Sexually Transmitted Infection (STI) 8. Evidence of pelvic inflammatory disease (PID) 9. Known clotting defects or bleeding disorders 10. Hemoglobin \< 8 g/dL 11. Metastatic disease 12. On anticoagulant therapy 13. Participation in another interventional trial 14. Pregnancy 15. Abnormal Papanicolaou test (PAP) results that have not been fully evaluated, or in the opinion of the investigator may indicate abnormal vaginal cuff healing 16. Co-morbidities that, in the opinion of the investigator, may indicate risk of abnormal vaginal cuff healing 17. Intra-operative: Bowel injury during laparoscopic hysterectomy procedure prior to attempted cuff closure 18. Intra-operative: Bladder injury during laparoscopic hysterectomy procedure prior to attempted cuff closure 19. Intra-operative: Cases in which surgeon cannot identify adequate tissue along the cuff to apply suture laparoscopically 20. Intra-operative: Cases requiring conversion to laparotomy prior to study intervention

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As listed by the trial registrant

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

Laparoscopic hysterectomy

Contacts and locations

Locations

  • Lankenau Hospital

    Wynnewood, Pennsylvania, 19096, United States

  • Mon Health Medical Center

    Morgantown, West Virginia, 26505, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Tidewater Clinical Research

    Virginia Beach, Virginia, 23456, United States

  • Unified Women's Clinical Research

    Winston-Salem, North Carolina, 27103, United States

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