NCT07508592Completed
Feasibility Study of the SEGER Device in Laparoscopic Gastrointestinal Surgery
A Prospective Study on the Usability and Clinical Outcomes of the SEGER IDEA™ Device for Enterotomy Closure
Source: ClinicalTrials.gov · Last updated 29 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 27 Mar 2026
- Start date
- 17 Feb 2026
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- Seger Surgical Solutions
- Diseases
- Crohn's disease, Obesity, Colorectal cancer
- NCT number
- NCT07508592
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From 17 Feb 2026 to the primary completion date, 1 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients in emergency surgery situations (urgent cases where study enrollment and the careful use of a new device are not feasible),
Other illness
- Patients with a known hypersensitivity to titanium or stainless steel (although rare, this relates to staple/anvil materials),
- 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
Other
- Patients with extensive intra-abdominal adhesions or anatomical abnormalities that would make intracorporeal anastomosis technically impossible,
- Pregnant patients.
Who the study is looking for
- 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).
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Nacional Zacamil Coordinator of this site? Confirm its status | San Salvador | El Salvador | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.