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Magnets may replace stitches in bowel surgery: new trial underway

NCT ID NCT07431723

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 special magnet system to connect sections of the large or small bowel during colorectal surgery, instead of traditional stitches or staples. About 50 people needing this type of surgery will take part. The goal is to see if the magnets can safely create a strong connection that allows the bowel to heal properly and pass naturally out of the body.

What this could mean

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

Active substance
Magnet System (device)
What this could lead to
If successful, this magnetic device could offer a safer, simpler way to reconnect the bowel after colorectal surgery, potentially reducing the need for additional surgeries.
What could go wrong
This is an early study with only 50 participants, so results may not apply to everyone. Risks include magnet failure, blockage, or the need for further surgery.

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 50 people

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

Started

Feb 2026

Expected to finish

Feb 2028

An estimate. End dates often move.

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 to 75 years

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: * Indicated for colorectal surgery requiring anastomosis within the colon or colon and distal small bowel (i.e., colocolic, colorectal, rectalrectal, ileocolic, or ileorectal) performed side-to-side or endto-end with ileostomy * Participant has been informed of the nature of the study and agrees to its provisions, complying with study required testing, medications, follow-up visits, and has provided written informed consent. Exclusion Criteria: * High frailty index, with a score of ≥ 3 on the five-item modified frailty index (mFI-5). * Severe Sarcopenia as determined by the investigator. * Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contraindicate the procedure, including scarring and abnormal anatomy at the target anastomosis sites. * Any anomaly precluding orogastric access by colonoscope and catheters, and manipulation techniques. * Any anomaly preventing / contraindicating colonoscopic or laparoscopic access and procedures. * Implantable pacemaker or defibrillator (and/or other devices that may be impacted by or interfere with the Magnet System). * Psychiatric disorder, except well-controlled depression with medication for \> 6 months. * Pregnant, lactating, or planning pregnancy during the clinical investigation. * Any comorbidity or current status of participant's physiological fitness that in the surgeon's or anesthesiologist's opinion represents safety concerns that make the participant medically unfit for the procedure, including any significant congenital or acquired anomalies of the GI tract at or distal to the placement of the Magnets. * Unhealed ulcers, bleeding lesions, tumor, or any other lesion at target Magnet deployment site. * Expected need for Magnetic Resonance Imaging (MRI) within the first 2 months post-procedure. * Any surgical or interventional procedure (including planned and/or scheduled) within the period of 30 days prior to and 30 days following the study procedure. * Any stroke/Transient Ischemic Attack (TIA) ≤ 6 months prior to consent. * Requires chronic anticoagulation therapy (except aspirin). * Active infections requiring antibiotic therapy, unless resolved before undergoing the study procedure. * Current tobacco / nicotine product usage or recent product cessation ≤ 3 months prior to informed consent. * Known allergies to the device components (including the biofragmentable material PGLA or similar compounds) or contrast media. * Participants with comorbidities that are likely to result in a life expectancy ≤ 12 months. * Currently participating in an investigational drug or another device study that has not reached its primary endpoint * Presence of other anatomic or comorbid conditions, or other medical, social or psychological conditions that, in the investigator's opinion, could limit the participant's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Clinica MEDS La Dehesa SpA

    RECRUITING

    Santiago, Chile

  • Policlinico San Marco, Bergamo

    RECRUITING

    Bergamo, Italy

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