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New device aims to simplify bowel surgery

NCT ID NCT07508592

Disease control Sponsor: Seger Surgical Solutions 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Updated 2 times

Summary

This study is testing a new device called SEGER IDEA™ that helps surgeons close openings in the bowel during keyhole surgery. It is the first time this device is being used in humans. Ten adults having certain types of bowel surgery will take part. The main goal is to see if the device is safe and works as intended.

What this could mean

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

Active substance
SEGER IDEA™ surgical device
What this could lead to
If successful, this device could make laparoscopic bowel surgery safer and easier for surgeons, potentially reducing complications like leaks.
What could go wrong
This is a very early, small study with only 10 people. The device is new and untested in humans, so it may not work as expected or could cause complications.

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

10 people

The number who actually took part.

Started

Feb 2026

Finished

Jun 2026

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 80 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: 1. Adults (e.g., age 18-80) who are candidates for * Laparoscopic ileocolic resection * Laparoscopic right hemicolectomy * Elective laparoscopic small bowel-small bowel anastomosis (including jejuno-jejunostomy and ileo-ileal anastomosis) performed as part of gastric bypass surgery (a maximum of 40% of the total enrolled population may consist of bariatric (gastric bypass) cases). 2. The surgeon has determined that an intracorporeal anastomosis is appropriate for the case, 3. The patient is able to provide informed consent and is willing to participate in the study, and 4. The patient has no condition that would preclude safe use of the device. Exclusion Criteria: 1. Patients in emergency surgery situations (urgent cases where study enrollment and the careful use of a new device are not feasible), 2. Patients with extensive intra-abdominal adhesions or anatomical abnormalities that would make intracorporeal anastomosis technically impossible, 3. Patients with a known hypersensitivity to titanium or stainless steel (although rare, this relates to staple/anvil materials), 4. Pregnant patients. 5. Patients with severe uncontrolled coagulopathy or other high-risk medical conditions that, in the judgment of the investigator and surgical team, do not allow for a safe surgical procedure

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Conditions

The condition(s) this trial relates to.

colonic neoplasm Crohn disease Obesity obesity disorder Overweight

As listed by the trial registrant

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

Anastomosis, surgical Colon neoplasms Crohn disease (CD) Enterotomy Gastrointestinal surgical procedures Laparoscopy-assisted surgery Obesity & overweight

Contacts and locations

Locations

  • Hospital Nacional Zacamil

    San Salvador, El Salvador

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