Anastomosis, SurgicalNCT06928545
MagDI U.S. Registry
An observational study of Anastomosis, Surgical and Internal Hernia, run by GT Metabolic Solutions, Inc. at 6 sites in United States.
Trial summary
Assess the incidence and severity of internal hernia and bowel obstruction at one year in a U.S. population following use of the MagDI System to create side-to-side duodeno-ileal anastomoses. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Anastomosis, Surgical, Internal Hernia, Bowel Obstruction
- What is being tested?
- Side-to-side duodenal-ileal anastomosis
- Type of treatment
- Medical device
- How many people
- 106 participants
- Where
- 6 sitesUnited States
- Study dates
- 28 Mar 2025to Apr 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
Study population: All eligible patients in the U.S. who undergo a side-to-side duodeno-ileal anastomosis with the MagDI System.
Who may be able to join
- >21 years of age, at the time of informed consent.
- Body Mass Index (BMI) between 30-50 kg/m2.
- Indicated for a side-to-side duodeno-ileal anastomosis and is treated with the MagDI System at a U.S. registry center.
- Participant has been informed of the nature of the registry.
Who cannot join
- 1. Participant does not provide informed consent to be enrolled and followed in the registry.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Bariatric Specialists of the Carolinas
Cary, North Carolina, 27518
Jamie Lee Bull, PA, jbullpabsc@gmail.com
Paul Enochs, MD
- Recruiting
Ochsner Clinic Foundation
Lafayette, Louisiana, 70503
Ashunti Pearson, aspearson@ochsner.org
Philip Gachassin, MD
- Recruiting
Baptist Healthcare System, Inc.
Louisville, Kentucky, 40299
Karin Cryan, karin.cryan@bhsi.com
John Oldham, MD
- Recruiting
Transform Weight Loss
Lynnwood, Washington, 98036
Josiah Billing, jbilling@transformweightloss.com
Peter Billing, MD
- Recruiting
HCA Florida Mercy
Miami, Florida, 33133
Ana Portela, ana.portela@hcahealthcare.com
Nestor de la Cruz, MD
- Recruiting
Ventura Advanced Surgical Associates
Ventura, California, 93003
Hellmuth Billy, 805-676-9100
Helmuth Billy, MD
About this study
Official title: Post-Market Assessment of the Incidence and Severity of Internal Hernia and Bowel Obstruction at One Year Following Use of the MagDI System to Create Side-to-Side Duodeno-Ileal Magnetic Compression Anastomoses (MagDI US Registry)
Assess the incidence and severity of internal hernia and bowel obstruction at one year in a U.S. population following use of the MagDI System to create side-to-side duodeno-ileal anastomoses.
Read the detailed description
Small bowel obstruction (SBO) following various abdominal and pelvic surgeries (0.4% - 13.9% at 5 years post-surgery) across obese and non-obese patients has been well studied in the scientific literature and found to be primarily due to intraperitoneal adhesions, with surgical technique (open surgery versus laparoscopic) cited as a key risk factor as reported in a retrospective population-based registry in Sweden (n=108,141). SBO incidence was reported as 3.2% for those undergoing bariatric surgery (n=1,896).
Given the MagDI System premarket clinical study (GTM-001) was conducted outside the U.S., FDA requires one post-market surveillance study to assess and characterize the incidence and severity of internal hernia and bowel obstruction in the U.S. intended use population treated with MagDI System. This study will be conducted through an observational patient registry and compare registry data to the premarket MagDI System clinical study data (GTM-001) and scientific literature. This post-market Registry Study was also a condition of the MagDI System FDA 510(k) clearances K242086 and K243359.
- Conditions
- Anastomosis, Surgical, Internal Hernia, Bowel Obstruction
- Being tested
- Side-to-side duodenal-ileal anastomosis
- Keywords
- GT Metabolic, MagDI System, Magnetic Anastomosis
- Medical subject headings
- Internal Hernia, Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Side-to-side duodenal-ileal anastomosisDevice
Side-to-side duodenal-ileal anastomosis formed by magnetic compression using the GT Metabolic MagDI System.
| Study group | Role | What they receive |
|---|---|---|
| MagDI System | Participants who underwent the MagDI System procedure and consented to participate in the Registry Receives: Device: Side-to-side duodenal-ileal anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Internal Hernia and Bowel Obstructions
To assess and characterize incidence and severity of internal hernia and bowel obstruction at one year in U.S. patients treated with the MagDI System compared with the pre-market study (GTM-001) and scientific literature.
Measured: From date of study index procedure through 360 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start28 Mar 2025
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomosis, SurgicalStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (estimated)
- Target duration
- 12 Months
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
- NCT06928545
- Sponsor's protocol ID
- GTM-007
- Status last verified
- Sep 2026
- First submitted
- 8 Apr 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Assessment of the Incidence and Severity of Internal Hernia and Bowel Obstruction at One Year Following Use of the MagDI System to Create Side-to-Side Duodeno-Ileal Magnetic Compression Anastomoses (MagDI US Registry)
- ClinicalTrials.gov ID
- NCT06928545
- Acronym / sponsor ID
- GTM-007
- Conditions
- Anastomosis, Surgical, Internal Hernia, Bowel Obstruction
- Keywords
- GT Metabolic, MagDI System, Magnetic Anastomosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- GT Metabolic Solutions, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 15 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.
Assess the incidence and severity of internal hernia and bowel obstruction at one year in a U.S. population following use of the MagDI System to create side-to-side duodeno-ileal anastomoses.
Detailed description
Small bowel obstruction (SBO) following various abdominal and pelvic surgeries (0.4% - 13.9% at 5 years post-surgery) across obese and non-obese patients has been well studied in the scientific literature and found to be primarily due to intraperitoneal adhesions, with surgical technique (open surgery versus laparoscopic) cited as a key risk factor as reported in a retrospective population-based registry in Sweden (n=108,141). SBO incidence was reported as 3.2% for those undergoing bariatric surgery (n=1,896).
Given the MagDI System premarket clinical study (GTM-001) was conducted outside the U.S., FDA requires one post-market surveillance study to assess and characterize the incidence and severity of internal hernia and bowel obstruction in the U.S. intended use population treated with MagDI System. This study will be conducted through an observational patient registry and compare registry data to the premarket MagDI System clinical study data (GTM-001) and scientific literature. This post-market Registry Study was also a condition of the MagDI System FDA 510(k) clearances K242086 and K243359.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MagDI System | – | Device: Side-to-side duodenal-ileal anastomosisParticipants who underwent the MagDI System procedure and consented to participate in the Registry |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible patients in the U.S. who undergo a side-to-side duodeno-ileal anastomosis with the MagDI System.
Key inclusion criteria (4 listed)
- >21 years of age, at the time of informed consent.
- Body Mass Index (BMI) between 30-50 kg/m2.
- Indicated for a side-to-side duodeno-ileal anastomosis and is treated with the MagDI System at a U.S. registry center.
- Participant has been informed of the nature of the registry.
Key exclusion criteria (1 listed)
- 1. Participant does not provide informed consent to be enrolled and followed in the registry.
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 |
|---|---|---|
| Side-to-side duodenal-ileal anastomosisSide-to-side duodenal-ileal anastomosis formed by magnetic compression using the GT Metabolic MagDI System. | Device | MagDI System |
Primary outcome
Incidence of Internal Hernia and Bowel Obstructions
Time frame: From date of study index procedure through 360 days.
To assess and characterize incidence and severity of internal hernia and bowel obstruction at one year in U.S. patients treated with the MagDI System compared with the pre-market study (GTM-001) and scientific literature.
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 10 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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anastomosis, Surgical and Internal Hernia, run by GT Metabolic Solutions, Inc. at 6 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 4 inclusion and 1 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 10 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 6 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 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?
Incidence of Internal Hernia and Bowel Obstructions (time frame: From date of study index procedure through 360 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 10 Sep 2026.