Colorectal CancerColonicNCT07276529
Initial Safety of SFM Plus OTOLoc for Creating Side-to-side or End-to-side Colorectal Anastomoses
A study testing Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Colon Anatomoses in people with Colorectal Cancer and Diverticular Diseases, run by GI Windows, Inc. at 2 sites in United States.
Trial summary
The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon 25mm SFM system plus OTOLoc when used to create a side-to-side Ileo-colic, Colo-colonic and side-to-side or end-to-side colorectal anastomoses in participants undergoing colon surgery. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Colorectal Cancer, Diverticular Diseases
- What is being tested?
- Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Colon Anatomoses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 22 years or older at screening
- Candidate for surgery requiring Right of Left Hemicolectomy or Sigmoidectomy or Low Anterior resection with cardiac/medical clearance for surgery
- Able to understand and sign informed consent document
- American Society of Anesthesiologists (ASA) score < IV at time of procedure
- All cancer patients must have completed chemotherapy ≥1 months prior to procedure
- Lives, and intends to remain, within a 150-mile radius of study center for the duration of the study
- Able to refrain from smoking during study follow-up period
Who cannot join
- Known or suspected allergy to silicone, nickel, titanium or Nitinol
- BMI > 55 kg/m2
- Uncontrolled diabetes (defined as HbA1c >10%)
- Congenital or acquired anomalies of the GI tract, including atresia or malrotation that would inhibit passing of SFM magnet
- Participants with an acute diagnosis of obstructed or perforated colon cancer at the time of the Screening Visit
- Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous failed endoscopy that may suggest difficulty during endoscopic delivery of magnets
Show all 19Show fewer
- History of recurrent small bowel obstructions.
- Coagulation deficiency not normalized by medical treatment or platelet count <50,000/µL
- Known moderate to severe renal disease (eGFR < 44 milliliters per minute per 1.73m2) or ongoing dialysis
- Hyperkalemia / hypercoagulability or prior Venus Thromboembolism / Pulmonary Embolism
- Immunocompromised (e.g., active treatment for malignancies, hematologic malignancy, on immunosuppressive therapy, moderate or severe primary immunodeficiency, advanced or untreated HIV, active treatment with high-dose corticosteroids (i.e., 20 or more mg of prednisone or equivalent per day when administered for 2 or more weeks prior to surgery) or other immunosuppressive or immunomodulatory agents
- Congestive heart failure with ejection fraction <35% or clinically significant arrhythmia (any rhythm disturbances except sinus tachycardia, sinus bradycardia or a sinus rhythm with premature atrial or ventricular complexes)
- Decompensated chronic obstructive lung disease
- Active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound.
- Contraindication to general anesthesia
- Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period
- Currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent
- Contraindication to general anesthesia
- Participant is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
University of Texas Health Science Center
Houston, Texas, 77030
Erik Askenasy, MD
Erik Askenasy, MD
- Recruiting
Orlando Health
Orlando, Florida, 32806
Antonio Caycedo, MD., MSc, 407-422-3790, antonio.caycedo@orlandohealth.com
About this study
Official title: Safety and Device Functionality of the Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Ileo-colic, Colo-colonic and Colorectal Anastomoses in Patients Undergoing Surgical Procedures
The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon 25mm SFM system plus OTOLoc when used to create a side-to-side Ileo-colic, Colo-colonic and side-to-side or end-to-side colorectal anastomoses in participants undergoing colon surgery. This will be evaluated via a composite safety/effectiveness endpoint of patient success defined as successful creation of the target anastomosis without placement procedure, device or target anastomosis related reoperation through 30 days.
Read the detailed description
This is a prospective, single-center, single-arm, early feasibility clinical study.
Patients who are scheduled for laparoscopic colon surgery requiring an anastomosis will be evaluated for participation in the study.
Study Cohorts:
- Roll-In (Training) Cohort: A roll-in phase will be included for centers that do not have previous experience with the SFM device. A maximum of 3 roll-in participants will be enrolled. Data from roll-in participants will be summarized separately from the Primary Analysis Cohort.
- Primary Analysis Cohort: A minimum of 17 participants undergoing side-to-side Ileo-colic, Colo-colonic and side-to-side or end-to-side colorectal anastomoses with the Flexagon 25mm SFM system plus OTOLoc.
Patients providing informed consent and meeting all eligibility criteria will be scheduled for surgery. All operations will be conducted by experienced general surgeons and gastroenterologists trained in the use of the Flexagon SFM System plus OTOLoc and procedures will be performed under general anesthesia.
Clinical follow-up for all participants will occur at Discharge, Day 7, 30, and 60.
- Conditions
- Colorectal Cancer, Diverticular Diseases
- Being tested
- Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Colon Anatomoses
- Medical subject headings
- Colorectal Neoplasms, Diverticular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Colon AnatomosesDevice
The SFM plus OTOLoc is used to create an immediate flow compression anastomosis for patients undergoing: Right or Left Hemicolectomy, Sigmoidectomy and Low Anterior resection
| Study group | Role | What they receive |
|---|---|---|
| Flexagon SFM plus OTOLoc for Magnet Colon Anastomosis | Experimental | Patients will receive the Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Ileo-colic, Colo-colonic and side-to-side or end-to-side Colorectal Anastomoses in Patients Undergoing Surgical Procedures via endoscopic or laparoscopic delivery methods Receives: Device: Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Colon Anatomoses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful anastomosis created with the Flexagon SFM plus OTOLoc without reoperation.
The study's primary endpoint (patient success) is defined as successful anastomosis created with the Flexagon SFM plus OTOLoc without placement procedure, device or target anastomosis-related reoperation through 30 days.
Measured: 30 days
Anastomosis success
is defined as creation of the target anastomosis without need for conversion to open procedure due to inability to create the magnet anastomosis using laparoscopic methods, intraoperative rescue procedure such as stapled or hand-sewed rescue of failed Flexagon SFM placement (i.e. - no magnet anastomosis created in patient) or intraoperative repair of adjacent organ
Measured: 30 days
Secondary outcomes (3)
No Bleeding at anastomosis
Bleeding Events through 30 days, defined as a target anastomosis related bleeding at the Flexagon SFM placement site requiring transfusion or re-operation.
Measured: 30 days
No Leaks at anastomosis
Flexagon SFM anastomosis Leak Events through 30 days, as defined by postoperative upper GI or CT evaluation with findings consistent with anastomosis leak, or re-operative findings consistent with anastomosis leak at the Flexagon SFM placement site
Measured: 30 days
No Obstructions at the anastomosis
Obstruction Events through 30 days as defined by the need for reintervention (e.g., endoscopic opening) or re-operation resulting from Flexagon SFM placement
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Apr 2026
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GI Windows, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erik Wilson, MD, Study chair, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276529
- Sponsor's protocol ID
- 25-004
- Acronym
- Colonic
- Status last verified
- Jul 2026
- First submitted
- 20 Nov 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Device Functionality of the Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Ileo-colic, Colo-colonic and Colorectal Anastomoses in Patients Undergoing Surgical Procedures
- ClinicalTrials.gov ID
- NCT07276529
- Acronym / sponsor ID
- Colonic / 25-004
- Conditions
- Colorectal Cancer, Diverticular Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- GI Windows, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Dec 2025 (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.
The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon 25mm SFM system plus OTOLoc when used to create a side-to-side Ileo-colic, Colo-colonic and side-to-side or end-to-side colorectal anastomoses in participants undergoing colon surgery. This will be evaluated via a composite safety/effectiveness endpoint of patient success defined as successful creation of the target anastomosis without placement procedure, device or target anastomosis related reoperation through 30 days.
Detailed description
This is a prospective, single-center, single-arm, early feasibility clinical study.
Patients who are scheduled for laparoscopic colon surgery requiring an anastomosis will be evaluated for participation in the study.
Study Cohorts:
- Roll-In (Training) Cohort: A roll-in phase will be included for centers that do not have previous experience with the SFM device. A maximum of 3 roll-in participants will be enrolled. Data from roll-in participants will be summarized separately from the Primary Analysis Cohort.
- Primary Analysis Cohort: A minimum of 17 participants undergoing side-to-side Ileo-colic, Colo-colonic and side-to-side or end-to-side colorectal anastomoses with the Flexagon 25mm SFM system plus OTOLoc.
Patients providing informed consent and meeting all eligibility criteria will be scheduled for surgery. All operations will be conducted by experienced general surgeons and gastroenterologists trained in the use of the Flexagon SFM System plus OTOLoc and procedures will be performed under general anesthesia.
Clinical follow-up for all participants will occur at Discharge, Day 7, 30, and 60.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flexagon SFM plus OTOLoc for Magnet Colon Anastomosis | Experimental | Device: Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Colon AnatomosesPatients will receive the Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Ileo-colic, Colo-colonic and side-to-side or end-to-side Colorectal Anastomoses in Patients Undergoing Surgical Procedures via endoscopic or laparoscopic delivery methods |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 22 years or older at screening
- Candidate for surgery requiring Right of Left Hemicolectomy or Sigmoidectomy or Low Anterior resection with cardiac/medical clearance for surgery
- Able to understand and sign informed consent document
- American Society of Anesthesiologists (ASA) score < IV at time of procedure
- All cancer patients must have completed chemotherapy ≥1 months prior to procedure
Key exclusion criteria (19 listed)
- Known or suspected allergy to silicone, nickel, titanium or Nitinol
- BMI > 55 kg/m2
- Uncontrolled diabetes (defined as HbA1c >10%)
- Congenital or acquired anomalies of the GI tract, including atresia or malrotation that would inhibit passing of SFM magnet
- Participants with an acute diagnosis of obstructed or perforated colon cancer at the time of the Screening Visit
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 |
|---|---|---|
| Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Colon AnatomosesThe SFM plus OTOLoc is used to create an immediate flow compression anastomosis for patients undergoing: Right or Left Hemicolectomy, Sigmoidectomy and Low Anterior resection | Device | Flexagon SFM plus OTOLoc for Magnet Colon Anastomosis |
Primary outcome
Successful anastomosis created with the Flexagon SFM plus OTOLoc without reoperation.
Time frame: 30 days
The study's primary endpoint (patient success) is defined as successful anastomosis created with the Flexagon SFM plus OTOLoc without placement procedure, device or target anastomosis-related reoperation through 30 days.
Anastomosis success
Time frame: 30 days
is defined as creation of the target anastomosis without need for conversion to open procedure due to inability to create the magnet anastomosis using laparoscopic methods, intraoperative rescue procedure such as stapled or hand-sewed rescue of failed Flexagon SFM placement (i.e. - no magnet anastomosis created in patient) or intraoperative repair of adjacent organ
3 secondary outcomes
No Bleeding at anastomosis
Time frame: 30 days
No Leaks at anastomosis
Time frame: 30 days
No Obstructions at the anastomosis
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 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.
Erik Wilson, MD study chair
Chief Medical Officer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Colon Anatomoses in people with Colorectal Cancer and Diverticular Diseases, run by GI Windows, Inc. at 2 sites in United States.
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 19 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter J Lukin, BS (9787610183, peter.lukin@giwindows.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful anastomosis created with the Flexagon SFM plus OTOLoc without reoperation. (time frame: 30 days). The study lists 2 primary outcomes in all. 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 6 Jul 2026.