Anastomosis, FunctionalMagCRNCT07431723
Creation of Compression Anastomosis Using the GT Metabolic Magnet System
A study testing Magnet System in people with Anastomosis, Functional and Colorectal, run by GT Metabolic Solutions, Inc. at 4 sites in 3 countries.
Trial summary
Evaluate the performance and safety of the Magnet System to create anastomoses throughout the large bowel and between the large and distal small bowel. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anastomosis, Functional, Colorectal
- What is being tested?
- Magnet System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 16 Feb 2026to Feb 2028
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indicated for colorectal surgery requiring anastomosis within the colon or colon and distal small bowel (i.e., colocolic, colorectal, rectalrectal, ileocolic, or ileorectal) performed side-to-side or endto-end with ileostomy
- Participant has been informed of the nature of the study and agrees to its provisions, complying with study required testing, medications, follow-up visits, and has provided written informed consent.
Who cannot join
- High frailty index, with a score of ≥ 3 on the five-item modified frailty index (mFI-5).
- Severe Sarcopenia as determined by the investigator.
- Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contraindicate the procedure, including scarring and abnormal anatomy at the target anastomosis sites.
- Any anomaly precluding orogastric access by colonoscope and catheters, and manipulation techniques.
- Any anomaly preventing / contraindicating colonoscopic or laparoscopic access and procedures.
- Implantable pacemaker or defibrillator (and/or other devices that may be impacted by or interfere with the Magnet System).
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- Psychiatric disorder, except well-controlled depression with medication for > 6 months.
- Pregnant, lactating, or planning pregnancy during the clinical investigation.
- Any comorbidity or current status of participant's physiological fitness that in the surgeon's or anesthesiologist's opinion represents safety concerns that make the participant medically unfit for the procedure, including any significant congenital or acquired anomalies of the GI tract at or distal to the placement of the Magnets.
- Unhealed ulcers, bleeding lesions, tumor, or any other lesion at target Magnet deployment site.
- Expected need for Magnetic Resonance Imaging (MRI) within the first 2 months post-procedure.
- Any surgical or interventional procedure (including planned and/or scheduled) within the period of 30 days prior to and 30 days following the study procedure.
- Any stroke/Transient Ischemic Attack (TIA) ≤ 6 months prior to consent.
- Requires chronic anticoagulation therapy (except aspirin).
- Active infections requiring antibiotic therapy, unless resolved before undergoing the study procedure.
- Current tobacco / nicotine product usage or recent product cessation ≤ 3 months prior to informed consent.
- Known allergies to the device components (including the biofragmentable material PGLA or similar compounds) or contrast media.
- Participants with comorbidities that are likely to result in a life expectancy ≤ 12 months.
- Currently participating in an investigational drug or another device study that has not reached its primary endpoint
- Presence of other anatomic or comorbid conditions, or other medical, social or psychological conditions that, in the investigator's opinion, could limit the participant's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Italy2 sites, 2 recruiting
- Recruiting
Policlinico San Marco, Bergamo
Bergamo
Sara Berva, +39 3317611886
Stefano Olmi, MD
- Recruiting
Ospedale Evangelco Betania
Naples
Anna Maria Pessina, +39 3478110414
Sonja Chiappetta, MD
Chile1 site, 1 recruiting
- Recruiting
Clinica MEDS La Dehesa SpA
Santiago
Francisca Quintana, +56 22 9015945
James Hamilton, MD
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinico San Carlos
Madrid
Jana Dziakova, MD, +34 91 3303184
Jose Maria Muguerza, MD
About this study
Official title: Creation of Compression Anastomosis Using the GT Metabolic Magnet System as Either the Primary or the First Stage of Colorectal Surgery (MagCR Study)
Evaluate the performance and safety of the Magnet System to create anastomoses throughout the large bowel and between the large and distal small bowel.
Read the detailed description
The objective of the MagCR Study is to evaluate the performance and safety of the Magnet System in eligible participants with colorectal disease as either primary or the first stage of surgical treatment. A magnetic compression anastomosis is fully reversable and may be considered for temporary staging of surgical treatments. Reversal of the compression anastomosis may be easily performed given the Magnet System leaves no foreign material behind (e.g., sutures or staples).
- Conditions
- Anastomosis, Functional, Colorectal
- Being tested
- Magnet System
- Keywords
- Magnet System, GT Metabolic Solutions, Inc.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnet SystemDevice
Anastomoses throughout the large bowel and between the large and distal small bowel achieved by magnetic compression.
| Study group | Role | What they receive |
|---|---|---|
| Magnet System | Experimental | GT Metabolic Magnet System comprised of GT Metabolic Magnet System ("Magnet System") Receives: Device: Magnet System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnet Placement
Successful placement and connection of the Magnets
Measured: 1 day
Natural Magnet Passage
Successful passage of magnets without surgical reintervention
Measured: 90 days
Anastomosis Patency
Creation of a patent anastomosis confirmed radiologically.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start16 Feb 2026
- Primary completionMar 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomosis, FunctionalStudies 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
- Model description
- A 2-stage, open-label, multicenter study enrolling up to 60 subjects at up to 6 study centers in Europe and South America: * Stage 1: First-in-human (FIH) and proof-of-concept with up to 5 evaluable subjects; and * Stage 2: Feasibility with a goal of up to 45 evaluable subjects There will be a pause after completing enrollment and follow up to Day 30 for all Stage 1 subjects, with evaluation of safety by the independent Data Safety Monitoring Board (DSMB) to determine ability to move to the subsequent. \*Note: Evaluable subjects are enrolled subjects (signed ICF) who successfully undergo the study procedure. The total of 60 allows for attrition to hit the study goal of 50 evaluable subjects.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GT Metabolic Solutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431723
- Sponsor's protocol ID
- GTM-014
- Acronym
- MagCR
- Status last verified
- Sep 2026
- First submitted
- 19 Feb 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of Compression Anastomosis Using the GT Metabolic Magnet System as Either the Primary or the First Stage of Colorectal Surgery (MagCR Study)
- ClinicalTrials.gov ID
- NCT07431723
- Acronym / sponsor ID
- MagCR / GTM-014
- Conditions
- Anastomosis, Functional, Colorectal
- Keywords
- Magnet System, GT Metabolic Solutions, Inc.
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- GT Metabolic Solutions, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 25 Feb 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.
Evaluate the performance and safety of the Magnet System to create anastomoses throughout the large bowel and between the large and distal small bowel.
Detailed description
The objective of the MagCR Study is to evaluate the performance and safety of the Magnet System in eligible participants with colorectal disease as either primary or the first stage of surgical treatment. A magnetic compression anastomosis is fully reversable and may be considered for temporary staging of surgical treatments. Reversal of the compression anastomosis may be easily performed given the Magnet System leaves no foreign material behind (e.g., sutures or staples).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A 2-stage, open-label, multicenter study enrolling up to 60 subjects at up to 6 study centers in Europe and South America: * Stage 1: First-in-human (FIH) and proof-of-concept with up to 5 evaluable subjects; and * Stage 2: Feasibility with a goal of up to 45 evaluable subjects There will be a pause after completing enrollment and follow up to Day 30 for all Stage 1 subjects, with evaluation of safety by the independent Data Safety Monitoring Board (DSMB) to determine ability to move to the subsequent. *Note: Evaluable subjects are enrolled subjects (signed ICF) who successfully undergo the study procedure. The total of 60 allows for attrition to hit the study goal of 50 evaluable subjects.
| Arm | Type | Receives |
|---|---|---|
| Magnet System | Experimental | Device: Magnet SystemGT Metabolic Magnet System comprised of GT Metabolic Magnet System ("Magnet System") |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indicated for colorectal surgery requiring anastomosis within the colon or colon and distal small bowel (i.e., colocolic, colorectal, rectalrectal, ileocolic, or ileorectal) performed side-to-side or endto-end with ileostomy
- Participant has been informed of the nature of the study and agrees to its provisions, complying with study required testing, medications, follow-up visits, and has provided written informed consent.
Key exclusion criteria (20 listed)
- High frailty index, with a score of ≥ 3 on the five-item modified frailty index (mFI-5).
- Severe Sarcopenia as determined by the investigator.
- Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contraindicate the procedure, including scarring and abnormal anatomy at the target anastomosis sites.
- Any anomaly precluding orogastric access by colonoscope and catheters, and manipulation techniques.
- Any anomaly preventing / contraindicating colonoscopic or laparoscopic access and procedures.
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 |
|---|---|---|
| Magnet SystemAnastomoses throughout the large bowel and between the large and distal small bowel achieved by magnetic compression. | Device | Magnet System |
Primary outcome
Magnet Placement
Time frame: 1 day
Successful placement and connection of the Magnets
Natural Magnet Passage
Time frame: 90 days
Successful passage of magnets without surgical reintervention
Anastomosis Patency
Time frame: 90 days
Creation of a patent anastomosis confirmed radiologically.
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 30 Sep 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.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnet System in people with Anastomosis, Functional and Colorectal, run by GT Metabolic Solutions, Inc. at 4 sites in 3 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 2 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 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy, Chile, Spain. 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 Lisa Griffin Vincent, PhD, MA (+1 763-200-1416, clinical@gtmetabolic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnet Placement (time frame: 1 day). The study lists 3 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 30 Sep 2026.