Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Neoplasms | Colon Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Crohn Disease (CD) | — | UNRESOLVED | — |
| Obesity & Overweight | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SEGER Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SEGER Device
- description
- The SEGER device is used intraoperatively during laparoscopic gastrointestinal surgery to facilitate closure of enterotomies and support intracorporeal anastomosis.
- interventionNames
- Device: SEGER Device
Primary outcomes (1)
- measure
- Incidence of anastomotic leaks
- timeFrame
- Within 30 days post-surgery
- description
- Incidence of anastomotic leaks within 30 days post-surgery, assessed by clinical symptoms, imaging findings, or need for reoperation.
Secondary outcomes (6)
- measure
- Technical success rate
- timeFrame
- Intraoperative
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available