CompletedNot Applicable

Feasibility Study of the SEGER Device in Laparoscopic Gastrointestinal Surgery

El Salvador10 participantsStarted 2026-02-17

Plain-language summary

This is a first-in-human feasibility study designed to evaluate the safety and performance of the SEGER device in patients undergoing elective laparoscopic gastrointestinal surgery requiring intracorporeal anastomosis. The study will include patients undergoing procedures such as small bowel-small bowel and colorectal anastomoses. The SEGER device is intended to facilitate closure of enterotomies and support intracorporeal anastomosis during minimally invasive surgery. The primary objective of the study is to assess the safety of the device and its performance during surgery. Secondary objectives include evaluation of technical success, intraoperative usability, and early postoperative outcomes.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adults (e.g., age 18-80) who are candidates for
. The surgeon has determined that an intracorporeal anastomosis is appropriate for the case,
. The patient is able to provide informed consent and is willing to participate in the study, and
. The patient has no condition that would preclude safe use of the device.

Exclusion criteria

. Patients in emergency surgery situations (urgent cases where study enrollment and the careful use of a new device are not feasible),
. Patients with extensive intra-abdominal adhesions or anatomical abnormalities that would make intracorporeal anastomosis technically impossible,

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of anastomotic leaks

Timeframe: Within 30 days post-surgery

Trial details

NCT IDNCT07508592

SponsorSeger Surgical Solutions

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-01

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