Colon NeoplasmsSEGER-FIHNCT07508592
Feasibility Study of the SEGER Device in Laparoscopic Gastrointestinal Surgery
A study testing SEGER Device in people with Colon Neoplasms and Crohn Disease (CD), run by Seger Surgical Solutions at 1 site in El Salvador.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Neoplasms, Crohn Disease (CD), Obesity & Overweight
- What is being tested?
- SEGER Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEl Salvador
- Study dates
- 17 Feb 2026to 5 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
- Patients with a known hypersensitivity to titanium or stainless steel (although rare, this relates to staple/anvil materials),
- Pregnant patients.
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study on the Usability and Clinical Outcomes of the SEGER IDEA™ Device for Enterotomy Closure
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.
Read the detailed description
This is a prospective, single-arm, 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 be conducted at a single clinical site in El Salvador. Eligible patients are adults undergoing elective laparoscopic procedures involving intracorporeal anastomosis, including but not limited to small bowel-small bowel (e.g., jejuno-jejunal) and colorectal anastomoses.
The SEGER device is intended to facilitate closure of enterotomies and support the creation of intracorporeal anastomoses during minimally invasive surgery. The device will be used intraoperatively according to the study protocol and the investigator's clinical judgment.
The primary objective of the study is to evaluate the safety of the device, including the incidence of device-related and procedure-related adverse events. Secondary objectives include assessment of device performance, technical success, intraoperative usability, and early postoperative outcomes.
Patients will be followed postoperatively according to the study protocol to assess clinical outcomes and recovery. Data collected will include intraoperative parameters, device performance metrics, and postoperative clinical outcomes.
- Conditions
- Colon Neoplasms, Crohn Disease (CD), Obesity & Overweight
- Being tested
- SEGER Device
- Keywords
- Laparoscopic surgery, Intracorporeal anastomosis, Enterotomy closure, Surgical device, Feasibility study
- Medical subject headings
- Colonic Neoplasms, Crohn Disease, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEGER DeviceDevice
The SEGER device is an investigational surgical device used during laparoscopic gastrointestinal procedures to facilitate intracorporeal closure of enterotomies and support small bowel anastomosis. The device is applied intraoperatively as part of the surgical workflow.
| Study group | Role | What they receive |
|---|---|---|
| SEGER Device | Experimental | The SEGER device is used intraoperatively during laparoscopic gastrointestinal surgery to facilitate closure of enterotomies and support intracorporeal anastomosis. Receives: Device: SEGER Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of anastomotic leaks
Incidence of anastomotic leaks within 30 days post-surgery, assessed by clinical symptoms, imaging findings, or need for reoperation.
Measured: Within 30 days post-surgery
Secondary outcomes (6)
Technical success rate
Proportion of procedures with successful deployment of the SEGER IDEA™ device without intraoperative complications.
Measured: Intraoperative
Incidence of postoperative complications
Incidence of postoperative complications including bleeding, infection, stricture formation, or device-related adverse events.
Measured: Within 30 days post-surgery
Time to complete enterotomy closure
Time from device deployment to completion of enterotomy closure.
Measured: Intraoperative
Length of hospital stay
Number of days from surgery to hospital discharge.
Measured: Up to 30 days post-surgery
Need for additional intraoperative interventions
Use of additional techniques such as reinforcement suturing or alternative closure methods.
Measured: Intraoperative
Patient recovery outcomes
Time to return to normal diet, bowel function, and physical activity.
Measured: Within 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start17 Feb 2026
- Primary completion1 Jun 2026
- Study completion5 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, non-randomized feasibility study in which all participants receive the SEGER device during laparoscopic surgery.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seger Surgical Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francisco José Alabi Montoya, MD, Principal investigator, Hospital Nacional ZacamilBarry Salky, MD, Study director, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508592
- Sponsor's protocol ID
- SS-Pr-01
- Acronym
- SEGER-FIH
- Status last verified
- Jun 2026
- First submitted
- 27 Mar 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Usability and Clinical Outcomes of the SEGER IDEA™ Device for Enterotomy Closure
- ClinicalTrials.gov ID
- NCT07508592
- Acronym / sponsor ID
- SEGER-FIH / SS-Pr-01
- Conditions
- Colon Neoplasms, Crohn Disease (CD), Obesity & Overweight
- Keywords
- Laparoscopic surgery, Intracorporeal anastomosis, Enterotomy closure, Surgical device, Feasibility study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Seger Surgical SolutionsIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 5 Jun 2026 (actual)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, single-arm, 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 be conducted at a single clinical site in El Salvador. Eligible patients are adults undergoing elective laparoscopic procedures involving intracorporeal anastomosis, including but not limited to small bowel-small bowel (e.g., jejuno-jejunal) and colorectal anastomoses.
The SEGER device is intended to facilitate closure of enterotomies and support the creation of intracorporeal anastomoses during minimally invasive surgery. The device will be used intraoperatively according to the study protocol and the investigator's clinical judgment.
The primary objective of the study is to evaluate the safety of the device, including the incidence of device-related and procedure-related adverse events. Secondary objectives include assessment of device performance, technical success, intraoperative usability, and early postoperative outcomes.
Patients will be followed postoperatively according to the study protocol to assess clinical outcomes and recovery. Data collected will include intraoperative parameters, device performance metrics, and postoperative clinical outcomes.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, non-randomized feasibility study in which all participants receive the SEGER device during laparoscopic surgery.
| Arm | Type | Receives |
|---|---|---|
| SEGER Device | Experimental | Device: SEGER DeviceThe SEGER device is used intraoperatively during laparoscopic gastrointestinal surgery to facilitate closure of enterotomies and support intracorporeal anastomosis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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,
- Patients with a known hypersensitivity to titanium or stainless steel (although rare, this relates to staple/anvil materials),
- Pregnant patients.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEGER DeviceThe SEGER device is an investigational surgical device used during laparoscopic gastrointestinal procedures to facilitate intracorporeal closure of enterotomies and support small bowel anastomosis. The device is applied intraoperatively as part of the surgical workflow. | Device | SEGER Device |
Primary outcome
Incidence of anastomotic leaks
Time frame: Within 30 days post-surgery
Incidence of anastomotic leaks within 30 days post-surgery, assessed by clinical symptoms, imaging findings, or need for reoperation.
6 secondary outcomes
Technical success rate
Time frame: Intraoperative
Incidence of postoperative complications
Time frame: Within 30 days post-surgery
Time to complete enterotomy closure
Time frame: Intraoperative
Length of hospital stay
Time frame: Up to 30 days post-surgery
Need for additional intraoperative interventions
Time frame: Intraoperative
Patient recovery outcomes
Time frame: Within 30 days post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco José Alabi Montoya, MD principal investigator
Hospital Nacional Zacamil
Barry Salky, MD study director
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEGER Device in people with Colon Neoplasms and Crohn Disease (CD), run by Seger Surgical Solutions at 1 site in El Salvador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in El Salvador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of anastomotic leaks (time frame: Within 30 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.