Colon AnastomosisFOCUSNCT06915818
Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery
A study testing Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and OTOLoc in people with Colon Anastomosis, run by GI Windows, Inc. at 2 sites in 2 countries.
Trial summary
The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to create a Ileo-colic and Colo-colonic 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
- Colon Anastomosis
- What is being tested?
- Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and OTOLoc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 29 Mar 2025to Nov 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 Hemicolectomy or Sigmoid / Low Anterior resection (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 ≥2 months 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 during endoscopic delivery of magnets
Show all 20Show fewer
- Any previous major surgery on the stomach, duodenum, hepatobiliary tree, pancreas, Whipple or right colon
- 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 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Chile1 site, 1 recruiting
- Not yet recruiting
Clinica Colonial Hospital
Santiago, Huechuraba, Región Metropolitana, 8580000
Pablo Marin, MD, +56982947291, doctorpablomarin@gmail.com
Francesca Gorziglia, MD, +56985007583, francesca.gorziglia@gmail.com
India1 site, 1 recruiting
- Recruiting
Mohak Hitech Specialty Hospital
Indore, Madhya Pradesh, 454555
Mohit Bhandari, MD, (+91) 7314231753
Mohit Bhandari, MD
About this study
Official title: GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Ileo-colic and Colo-colonic Anastomoses in Patients Undergoing Surgical Procedures
The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to create a Ileo-colic and Colo-colonic anastomoses in participants undergoing colon surgery.
Read the detailed description
This is a prospective, multi-center, single-arm clinical study to evaluate the GI Windows Flexagon Self Forming Magnet Anastomosis plus OTOLoc for creating Ileo-colic and Colo-colonic anastomoses in participants undergoing colon surgery.
- Conditions
- Colon Anastomosis
- Being tested
- Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and OTOLoc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and OTOLocDevice
This study will investigate two types of intervention: ileo-colic and colo-colonic anastomosis creation in subjects undergoing colon surgery. Flexagon SFMs and OTOLoc devices will be delivered laparoscopically and/or endoscopically into a portion of either the ileum or the colon that are intended to be anastomosed. An OTOLoc device will be deployed into the ileum/colon wall to provide access for the deployment of a Flexagon SFM into the bowel. The process is repeated at an intended section of colon. Once deployed, the Flexagon SFMs are approximated and positioned, after which the SFMs are couple together to form the anastomosis, with the OTOLoc devices allowing fluidic communication between the two lumens until the anastomosis is fully formed.
| Study group | Role | What they receive |
|---|---|---|
| Study Group: Prospective Evaluation of Flexagon SFM Device with OTOLoc | Experimental | This is a multicenter, single-arm study in which clinical outcomes are prospectively evaluated for subjects undergoing ileo-colic and colo-colonic anastomosis using the Flexagon SFM Device with OTOLoc. Receives: Device: Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and OTOLoc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Successful Anastomosis Creation without the Need for Reoperation
The study's primary endpoint (patient success) is defined as successful anastomosis created with the Flexagon 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 posted8 Apr 2025
- Study start29 Mar 2025
- Primary completionAug 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon 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
- 65 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 HospitalVinod Dhakkad, MD, Principal investigator, Mohak Hitech Specialty HospitalPablo Marin, MD, Principal investigator, Clinica Colonial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915818
- Sponsor's protocol ID
- GIW 25-003
- Acronym
- FOCUS
- Status last verified
- Jul 2026
- First submitted
- 2 Apr 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to make IPD available.
Publications
Caycedo-Marulanda A, Bhandari M, Reddy M, Mathur W, Nguyen AD, Galvao Neto M. Magnetic Compression Anastomosis With Immediate Luminal Patency in Colorectal Surgery: First-in-Human Safety and Feasibility Evaluation of a Self-forming Magnet System. Dis Colon Rectum. 2026 Nov 1;69(11):2738-2743. doi: 10.1097/DCR.0000000000004309. Epub 2026 Jun 26.
PubMed 42962210
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
- GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Ileo-colic and Colo-colonic Anastomoses in Patients Undergoing Surgical Procedures
- ClinicalTrials.gov ID
- NCT06915818
- Acronym / sponsor ID
- FOCUS / GIW 25-003
- Conditions
- Colon Anastomosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- GI Windows, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 8 Apr 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 SFM system plus OTOLoc when used to create a Ileo-colic and Colo-colonic anastomoses in participants undergoing colon surgery.
Detailed description
This is a prospective, multi-center, single-arm clinical study to evaluate the GI Windows Flexagon Self Forming Magnet Anastomosis plus OTOLoc for creating Ileo-colic and Colo-colonic anastomoses in participants undergoing colon surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group: Prospective Evaluation of Flexagon SFM Device with OTOLoc | Experimental | Device: Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and OTOLocThis is a multicenter, single-arm study in which clinical outcomes are prospectively evaluated for subjects undergoing ileo-colic and colo-colonic anastomosis using the Flexagon SFM Device with OTOLoc. |
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 Hemicolectomy or Sigmoid / Low Anterior resection (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 ≥2 months 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 |
|---|---|---|
| Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and OTOLocThis study will investigate two types of intervention: ileo-colic and colo-colonic anastomosis creation in subjects undergoing colon surgery. Flexagon SFMs and OTOLoc devices will be delivered laparoscopically and/or endoscopically into a portion of either the ileum or the colon that are intended to be anastomosed. An OTOLoc device will be deployed into the ileum/colon wall to provide access for the deployment of a Flexagon SFM into the bowel. The process is repeated at an intended section of colon. Once deployed, the Flexagon SFMs are approximated and positioned, after which the SFMs are couple together to form the anastomosis, with the OTOLoc devices allowing fluidic communication between the two lumens until the anastomosis is fully formed. | Device | Study Group: Prospective Evaluation of Flexagon SFM Device with OTOLoc |
Primary outcome
Number of Participants with Successful Anastomosis Creation without the Need for Reoperation
Time frame: 30 Days
The study's primary endpoint (patient success) is defined as successful anastomosis created with the Flexagon 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 6 Jul 2026.
- Derived from this study: PubMed 42962210Caycedo-Marulanda A, Bhandari M, Reddy M, Mathur W, Nguyen AD, Galvao Neto M. Magnetic Compression Anastomosis With Immediate Luminal Patency in Colorectal Surgery: First-in-Human Safety and Feasibility Evaluation of a Self-forming Magnet System. Dis Colon Rectum. 2026 Nov 1;69(11):2738-2743. doi: 10.1097/DCR.0000000000004309. Epub 2026 Jun 26.
- Individual participant dataSharing planned: No. There is no plan to make IPD available.
Related trials for Colon Anastomosis
Recruiting
Pre-emptive Endoscopic Vacuum Therapy Reduces the Incidence of Anastomotic Leakage After Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Surgery
Not yet recruiting
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
Rectal Cancer Patients, Rectal Cancer Surgery
Enrolling by invitation
Reinforced Versus Conventional Anastomosis in Laparoscopic Low Rectal Cancer Resection: A Comparative Study
Low Rectal Cancer, Rectal Neoplasms
Recruiting
Perioperative Biomarkers in Colorectal and Gastric Cancer Surgery
Colorectal (Colon or Rectal) Cancer, STOMACH NEOPLASM
Recruiting
ColoSeal™ ICD System Safety and Feasibility Studies
Colorectal Cancer
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
Vinod Dhakkad, MD principal investigator
Mohak Hitech Specialty Hospital
Pablo Marin, MD principal investigator
Clinica Colonial Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and OTOLoc in people with Colon Anastomosis, run by GI Windows, Inc. at 2 sites in 2 countries.
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: 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 Chile, India. 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 Lukin (+1 7814717901, peter.lukin@giwindows.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Successful Anastomosis Creation without the Need for Reoperation (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06915818, which also lists 1 linked publication.
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.