Colo-rectal AnastomosisFOCUS IINCT07856342
Megagon Magnet Anastomosis Plus OTOLoc for Creating Colo-colonic and Colorectal Anastomoses
A study testing Megagon Self-Forming Magnet in people with Colo-rectal Anastomosis, run by GI Windows, Inc..
Trial summary
The primary objective of this trial is to investigate the safety and effectiveness of the Megagon 28.5mm SFM system plus OTOLoc when used to create a colo-colonic and colorectal anastomosis in participants undergoing colon surgery. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Colo-rectal Anastomosis
- What is being tested?
- Megagon Self-Forming Magnet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 16 Nov 2026to 30 Mar 2027
- 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 Colo-colonic or colo-rectal (with anastomosis above the peritoneal reflection) 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 month prior to procedure
- Lives, and intends to remain, within a 300 kilometers 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
- Diagnosed with obstructed or perforated colon cancer
- Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy that may suggest difficulty for magnet passage
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- Any previous major surgery on the stomach, duodenum, hepatobiliary tree, pancreas, Whipple or right colon
- 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 Venous 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.
- A minimum cessation window of four (4) weeks prior to surgery for all biologic agents
- Restarted no earlier than four (4) weeks postoperatively
- 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 / or is receiving/has received an investigational drug, device, or biologic agent within past 4 weeks
- Participant is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: GI Windows Megagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating 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 Megagon 28.5mm SFM system plus OTOLoc when used to create a colo-colonic and colorectal anastomosis 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 clinical study.
Patients who are scheduled for laparoscopic or hybrid colon surgery requiring an anastomosis will be evaluated for participation in the study.
Up to 30 participants undergoing colo-colonic and colorectal anastomoses with the Megagon 28.5mm 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 Megagon SFM System plus OTOLoc, and procedures will be performed under general anesthesia. The anastomosis formation is achieved by creation of a colotomy in the (colon) utilizing a standard electrosurgical hook or equivalent, delivery of the OTOLoc into the colotomy, followed by delivery of the Megagon SFM through the OTOLoc into the colon with the FlexFire Universal 2, FlexFire delivery tools and the transrectal Nexus delivery system. Upon deployment, the SFM assembly self-forms into its closed octagonal shape and is ready for coupling with the second SFM. The same process is used for the second location in the rectum or colon. When the two SFMs are positioned to be in close proximity, coupling occurs, clamping the targeted intestinal tissue together, thereby starting the formation of a compression anastomosis.
After surgery, participants will be started on clear liquids and ambulation on the day of the procedure through postoperative Day 2. On postoperative Day 3, the diet will be advanced to full liquids excluding dairy products. On postoperative Day 5, participants may progress to a regular diet excluding all high-fiber foods (specifically vegetables, fruits, oatmeal, legumes, and other high-residue foods). Unrestricted regular diet will be permitted after postoperative Day 10. All dietary progression is subject to individual participant tolerance and investigator judgment. All participants will be required to stay in the hospital a minimum of one night per standard of care (SOC).
Clinical follow-up for all participants will occur at Discharge, Day 7, 30, and 60.
- Conditions
- Colo-rectal Anastomosis
- Being tested
- Megagon Self-Forming Magnet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Megagon Self-Forming MagnetDevice
Megagon Self-Forming Magnet
| Study group | Role | What they receive |
|---|---|---|
| Patients who are scheduled for laparoscopic or hybrid colon surgery requiring an anastomosis will be | Experimental | Anastomosis Receives: Device: Megagon Self-Forming Magnet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
The study's primary endpoint (patient success) is defined as successful anastomosis created with the Megagon SFM without placement procedure, device or target anastomosis-related reoperation through 30 days.
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 posted2 Oct 2026
- Study start16 Nov 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal AnastomosisStudies 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
- Mohit Bhandari, MD, Principal investigator, Mohak Hitech Specialty Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856342
- Sponsor's protocol ID
- GIW 26-002
- Acronym
- FOCUS II
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data is only feasibility data
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GI Windows Megagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Colo-colonic and Colorectal Anastomoses in Patients Undergoing Surgical Procedures
- ClinicalTrials.gov ID
- NCT07856342
- Acronym / sponsor ID
- FOCUS II / GIW 26-002
- Conditions
- Colo-rectal Anastomosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- GI Windows, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 2 Oct 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.
The primary objective of this trial is to investigate the safety and effectiveness of the Megagon 28.5mm SFM system plus OTOLoc when used to create a colo-colonic and colorectal anastomosis 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 clinical study.
Patients who are scheduled for laparoscopic or hybrid colon surgery requiring an anastomosis will be evaluated for participation in the study.
Up to 30 participants undergoing colo-colonic and colorectal anastomoses with the Megagon 28.5mm 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 Megagon SFM System plus OTOLoc, and procedures will be performed under general anesthesia. The anastomosis formation is achieved by creation of a colotomy in the (colon) utilizing a standard electrosurgical hook or equivalent, delivery of the OTOLoc into the colotomy, followed by delivery of the Megagon SFM through the OTOLoc into the colon with the FlexFire Universal 2, FlexFire delivery tools and the transrectal Nexus delivery system. Upon deployment, the SFM assembly self-forms into its closed octagonal shape and is ready for coupling with the second SFM. The same process is used for the second location in the rectum or colon. When the two SFMs are positioned to be in close proximity, coupling occurs, clamping the targeted intestinal tissue together, thereby starting the formation of a compression anastomosis.
After surgery, participants will be started on clear liquids and ambulation on the day of the procedure through postoperative Day 2. On postoperative Day 3, the diet will be advanced to full liquids excluding dairy products. On postoperative Day 5, participants may progress to a regular diet excluding all high-fiber foods (specifically vegetables, fruits, oatmeal, legumes, and other high-residue foods). Unrestricted regular diet will be permitted after postoperative Day 10. All dietary progression is subject to individual participant tolerance and investigator judgment. All participants will be required to stay in the hospital a minimum of one night per standard of care (SOC).
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 |
|---|---|---|
| Patients who are scheduled for laparoscopic or hybrid colon surgery requiring an anastomosis will be | Experimental | Device: Megagon Self-Forming MagnetAnastomosis |
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 Colo-colonic or colo-rectal (with anastomosis above the peritoneal reflection) 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 month prior to procedure
Key exclusion criteria (20 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
- Diagnosed with obstructed or perforated colon cancer
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 |
|---|---|---|
| Megagon Self-Forming MagnetMegagon Self-Forming Magnet | Device | Patients who are scheduled for laparoscopic or hybrid colon surgery requiring an anastomosis will be |
Primary outcome
Primary Endpoint
Time frame: 30 Days
The study's primary endpoint (patient success) is defined as successful anastomosis created with the Megagon SFM without placement procedure, device or target anastomosis-related reoperation through 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 2 Oct 2026.
- Individual participant dataSharing planned: Undecided. Data is only feasibility data
Related trials for Colo-rectal Anastomosis
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Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy
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Initial Safety of SFM Plus OTOLoc for Creating Side-to-side or End-to-side Colorectal Anastomoses
Colorectal Cancer, Diverticular Diseases
Not yet recruiting
Post Operative Hospital at Home After Colorectal Surgery
Colo-rectal Cancer, Colo-rectal Surgery
Not yet recruitingPhase 3
The Use of Indocyanine Green Near-infrared Fluorescence for Bowel Perfusion Quantitative Assessment in Order to Prevent Anastomotic Leakage in Colorectal Surgery
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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.
Mohit Bhandari, MD principal investigator
Mohak Hitech Specialty Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Megagon Self-Forming Magnet in people with Colo-rectal Anastomosis, run by GI Windows, Inc..
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 20 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: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Lukin COO (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?
Primary Endpoint (time frame: 30 Days). 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 2 Oct 2026.