Actively Recruiting
Feasibility Study of the SEGER Device in Laparoscopic Gastrointestinal Surgery
Led by Seger Surgical Solutions · Updated on 2026-04-02
10
Participants Needed
1
Research Sites
28 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Feasibility Study of the SEGER Device in Laparoscopic Gastrointestinal Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Candidates for laparoscopic ileocolic resection, laparoscopic right hemicolectomy, or elective laparoscopic small bowel-small bowel anastomosis
- Intracorporeal anastomosis determined appropriate by the surgeon
- Able and willing to provide informed consent and participate in the study
- No condition preventing safe use of the SEGER device
You will not qualify if you...
- Emergency surgery patients where study enrollment or device use is not feasible
- Extensive intra-abdominal adhesions or anatomical abnormalities making intracorporeal anastomosis impossible
- Known hypersensitivity to titanium or stainless steel
- Pregnant patients
- Severe uncontrolled coagulopathy or other high-risk medical conditions preventing safe surgery as judged by the investigator and surgical team
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Nacional Zacamil
San Salvador, El Salvador
Actively Recruiting
Research Team
T
Tal Lavi, Ph.D.
CONTACT
J
Jeniffer Bonilla, B.Sc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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