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New stomach stitcher aims to cut surgery risks

NCT ID NCT07315893

Disease control Sponsor: Anchora Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new device called Su2ura® GI that helps doctors stitch up the stomach wall after removing abnormal tissue. It involves 25 adults who need a stomach polyp removal procedure. The main goal is to see if the device is safe and can prevent problems like bleeding, infection, or leaks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Su2ura® GI system (a suturing device)
What this could lead to
If it works, this device could offer a safer way to close stomach tissue after polyp removal, reducing complications like bleeding or leaks.
What could go wrong
This is a small, early safety study with only 25 people. The device may not work as hoped, and risks include infection, bleeding, or incomplete closure.

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

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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

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 Criteria: 1. Age ≥18 years 2. Patient is able to provide informed consent . 3. Body mass index (BMI) 20-40 kg/m2 4. Patient is referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of a gastric neoplastic lesion 5. Candidate for endoscopic defect closure based on the operating's endoscopist assessment. Exclusion Criteria: 1. Patient with severe comorbidities likely to limit survival to less than 2 years. 2. Patients with INR\>1.5 3. Patients with PLT\< 150 4. Patient with known collagen or connective tissue disorders (e.g. scleroderma, marfan syndrome) . 5. Pregnant women or those intending to become pregnant during the study period 6. Patient with ascites on physical examination or CT scan. 7. Patient with varices. 8. Patient on peritoneal dialysis. 9. Patient with wound-healing disorders. 10. Patient with significant coagulation disorders or those requiring anti thrombotic or anticoagulation treatment other than aspirin . 11. Patient with autoimmune disorder requiring more than 10 mg of corticosteroid daily . 12. Patients in need of immunomodulatory therapy. 13. Immunocompromised patients (e.g., HIV/AIDS, organ transplant, chemo- or radiation therapy 6 months prior to recruitment). 14. Patient in need of concomitant surgical procedures other than those permitted in the protocol. 15. Non-compliance with the study protocol. 16. Patient requests to exist the study. -

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Conditions

The condition(s) this trial relates to.

gastric neoplasm

As listed by the trial registrant

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

Endoscopic mucosal resection Endoscopic submucosal dissection (ESD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tel-Aviv Sourasky Medical Center, Ichilov

    RECRUITING

    Tel Aviv, Israel

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