SEGER device to aid enterotomy closure and intracorporeal anastomosis during laparoscopic gastrointestinal surgery.
A Prospective Study on the Usability and Clinical Outcomes of the SEGER IDEA™ Device for Enterotomy Closure
This study will try the SEGER device in adults having elective laparoscopic intestinal surgery to help surgeons close enterotomies and perform intracorporeal anastomoses.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Seger Surgical Solutions Industry-sponsored |
| Locations | 1 site (San Salvador) |
| Trial ID | NCT07508592 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm, first-in-human feasibility study conducted at a single site in El Salvador enrolling adults undergoing elective laparoscopic procedures that require intracorporeal anastomosis. The SEGER device will be used intraoperatively to facilitate enterotomy closure and support creation of small bowel and colorectal anastomoses according to a predefined protocol and the surgeon's judgment. Primary outcomes focus on device- and procedure-related safety events, while secondary outcomes include technical success, intraoperative usability, and early postoperative recovery metrics. Patients will be followed postoperatively with collection of intraoperative parameters, device performance data, and short-term clinical outcomes.
Who should consider this trial
Good fit: Adults (approximately 18–80 years) scheduled for elective laparoscopic procedures requiring intracorporeal anastomosis—including ileocolic resection, right hemicolectomy, and small bowel–small bowel anastomoses, with up to 40% of enrollees allowed to be gastric bypass cases—are eligible if the surgeon plans an intracorporeal approach and the patient can consent.
Not a fit: Patients undergoing emergency surgery, those with extensive intra-abdominal adhesions or anatomical abnormalities that make intracorporeal anastomosis impossible, or those with contraindications to device use are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the device could simplify and speed intracorporeal anastomosis and enterotomy closure during minimally invasive bowel surgery, potentially reducing operative difficulty and complications.
How similar studies have performed: This is a first-in-human study of the SEGER device, so the specific device is novel in humans though other stapling and closure technologies for intracorporeal anastomosis have prior clinical experience.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Salvador
- Hospital Nacional Zacamil — San Salvador, El Salvador (Recruiting)
Study contacts
- Principal investigator: Francisco José Alabi Montoya, MD — Hospital Nacional Zacamil
- Study coordinator: Tal Lavi, Ph.D.
- Email: talnewmail@gmail.com
- Phone: +972527465388
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.