Diabete Type 2NCT07495787
Magnetic Compression Anastomosis Procedure for Partial Jejunoileal Anastomosis: Assessing the Viability of an Innovative Metabolic Approach
A study testing Magnetic Compression Anastomosis in people with Diabete Type 2, run by iIDEAS Group Holdings Limited at 1 site in India.
Trial summary
English, Hindi and Gujarati Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Diabete Type 2
- What is being tested?
- Magnetic Compression Anastomosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIndia
- Study dates
- 22 Apr 2025to 30 Sep 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be included in the study if they meet the following criteria:
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged ≥ 25 years to ≤ 65 years.
- BMI greater than or equal to 25 and less than 50
- Clinical diagnosis of T2DM by plasma glucose criteria, either the fasting plasma glucose (FPG) value or the 2-h plasma glucose (2-h PG) value during a 75-g oral glucose tolerance test (OGTT), or A1C criteria
- Glycated Hemoglobin greater than or equal to 7.5% and less than 10.5% in at least one laboratory analysis conducted within the past 3 months, typically associated with a recommendation by patient's primary care physician and/or endocrinologist for intensification of treatment beyond oral medications
- Currently taking oral combination therapy for T2DM
- At least 12 months of experience with Diabetes Self-Management and Support
Who cannot join
- 1. Pregnancy or breastfeeding mothers, or individuals planning to become pregnant in next 9-12 months 2. Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.) 3. Current enrolment in another research study or previous participation within 30 days of enrolment 4. Current history of injected Glucagon Like Peptide 1 (GLP1) 5. American Society of Anesthesiologists (ASA) physical classification level of 4 or greater 6. Hypoglycemia unawareness or a history of severe hypoglycemia (more than 1 severe hypoglycemic event, as defined by need for third-party-assistance, in the last year) 7. Evidence of type 1 diabetes or of pancreatic exhaustion, as indicated by a C peptide fasting level less than 1 or, for type 1 diabetes, based on measurable levels of serum anti-GAD-65 autoantibodies or, at investigator's discretion, based on measurable levels of other T1D-associated autoantibodies 8. History of highly unusual or challenging gastrointestinal tract anatomy ascertained through earlier endoscopic examination or other diagnostic imaging 9. History of (or known to be at prohibitive risk for) any of the following diseases of the small bowel or closely related conditions: Crohn's disease or other inflammatory bowel disease, celiac disease, resection for cancer, or intra-abdominal adhesive disease including intussusception, perforated appendix and Meckel's diverticulum 10. History of small bowel surgery such as small bowel resection 11. Active H. pylori infection (prospective participants with active H. pylori may continue with the screening process if they are treated via medication and re-testing verifies the condition has resolved.) 12. History of chronic or acute pancreatitis 13. Known active hepatitis or active liver disease 14. Symptomatic gallstones or kidney stones or acute cholecystitis
- Subjects will be deemed ineligible to participate if they fulfill any of the following criteria:
- Pregnancy or breastfeeding mothers, or individuals planning to become pregnant in next 9-12 months
- Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.)
- Current enrolment in another research study or previous participation within 30 days of enrolment
- Current history of injected Glucagon Like Peptide 1 (GLP1)
Show all 30Show fewer
- American Society of Anesthesiologists (ASA) physical classification level of 4 or greater
- Hypoglycemia unawareness or a history of severe hypoglycemia (more than 1 severe hypoglycemic event, as defined by need for third-party-assistance, in the last year)
- Evidence of type 1 diabetes or of pancreatic exhaustion, as indicated by a C peptide fasting level less than 1 or, for type 1 diabetes, based on measurable levels of serum anti-GAD-65 autoantibodies or, at investigator's discretion, based on measurable levels of other T1D-associated autoantibodies
- History of highly unusual or challenging gastrointestinal tract anatomy ascertained through earlier endoscopic examination or other diagnostic imaging
- History of (or known to be at prohibitive risk for) any of the following diseases of the small bowel or closely related conditions: Crohn's disease or other inflammatory bowel disease, celiac disease, resection for cancer, or intra-abdominal adhesive disease including intussusception, perforated appendix and Meckel's diverticulum
- History of small bowel surgery such as small bowel resection
- Active H. pylori infection (prospective participants with active H. pylori may continue with the screening process if they are treated via medication and re-testing verifies the condition has resolved.)
- History of chronic or acute pancreatitis
- Known active hepatitis or active liver disease
- Symptomatic gallstones or kidney stones or acute cholecystitis
- History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
- Use of anticoagulation therapy (such as warfarin) which cannot be discontinued for 7 days before and 14 days after the procedure
- Use of P2Y12 inhibitors (clopidogrel, pasugrel, ticagrelor) which cannot be discontinued for 14 days before and 14 days after the procedure (use of low-dose aspirin allowable)
- History of serious complications of T2DM including coronary artery disease, hypertension, peripheral vascular disease, diabetic retinopathy, and/or diabetes-related soft tissue infection
- Taking corticosteroids or drugs known to affect GI motility (e.g. Metoclopramide)
- Receiving weight loss medications such as Meridia, Xenical, or over-the-counter weight loss medications
- Persistent anemia, defined as Hgb<10 g dL-1
- Estimated Glomerular Filtration Rate (eGFR) or Modified of Diet in Renal Disease (MDRD) <30 ml/min/1.73m2
- Active systemic infection
- Currently on anticoagulation therapy other than a low-dose aspirin regimen
- Chemotherapeutic cancer treatment within past 9 months, history of abdominal radiation, or active malignancy within the past 5 years
- Active illicit substance abuse or alcoholism
- Known sensitivity to possible medications used before, during, or after the Connect procedure, including but not limited to the following: sedative agents, general anesthetics, topical anesthetics, and opioid analgesics
- Any other serological markers likely to be associated with poor outcomes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
AB Plus Speciality Hospital
Ahmedabad, Gujarat, 380054
Purvi A Chavda, MD, 08905818034, purvi@curexbio.com
About this study
English, Hindi and Gujarati
Read the detailed description
Title: Magnetic Compression Anastomosis Procedure for Partial Jejunoileal Anastomosis: Assessing the Viability of an Innovative Metabolic Approach Protocol Number 2025/01/EDIT Trial Type Investigator Initiated Trial This investigator-initiated trial (IIT) is a prospective, single-center, single-arm observation study in patients designed to explore metabolic indicator and procedural outcomes in patients with T2DM. A total of 5 patients with T2DM will be recruited in the study. Following the administration of general anesthesia, surgeon will introduce the ring component of the magnetic compression anastomosis system through an enterotomy. The insertion of the distal ring into the terminal ileum via an enterotomy, positioned approximately 30 cm proximal to the ileocecal valve, utilizing a laparoscopic deployment instrument. The proximal ring is then placed in the proximal jejunum, located around 20 cm (with a variance of ± 10 cm) distal to the ligament of Treitz. Laparoscopic techniques are employed to maneuver the bowel, aligning the proximal and distal magnets for effective magnetic coupling and observing the ring pair mating via intraoperative imaging (fluoroscopy or plain x-ray). This IIT will be conducted in single centre in India by a qualified investigator. It will be initiated after Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
The anticipated timeline for this study is as follows:
- Study Participant Enrollment: 02 months
- Procedure Period: 01 day
- Post procedure care: As suggested by the PI
- Safety and functionality follow-up: 6 weeks, 3 months, 6 months, 9 months
- Additional indications of efficacy follow-up: 12 months
- Conditions
- Diabete Type 2
- Being tested
- Magnetic Compression Anastomosis
- Keywords
- Magnetic Compression Anastomosis
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Compression AnastomosisDevice
This is an Investigator Initiated trial, prospective, single-center, single-arm observational study in patients with Type II Diabetes Mellitus (T2DM). A total of 5 patients with T2DM will be recruited in the study. Following the administration of general anesthesia, surgeon will introduce the ring component of the magnetic compression anastomosis system through an enterotomy. Laparoscopic techniques are employed to maneuver the bowel, aligning the proximal and distal magnets for effective magnetic coupling and observing the ring pair mating via intraoperative imaging (fluoroscopy or plain x-ray).
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Anastomosis | Experimental | Not described Receives: Device: Magnetic Compression Anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placement success rate - ≥ 90% alignment of magnets Passage of magnets without surgical re-intervention Safety
evaluating Placement success rate Passage of magnets without surgical re-intervention Radiological confirmation of patent anastomosis Safety profile To monitor the safety profile of the device by assessing the incidence and severity of procedural and device related complications or adverse events
Measured: Changes in glycosylated hemoglobin A1c (HbA1c) levels will be observed from baseline, 3 months, 6 months, 9 months and at 12 months following the index procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start22 Apr 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies 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
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iIDEAS Group Holdings Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495787
- Sponsor's protocol ID
- 2025/01/EDIT
- Status last verified
- Mar 2026
- First submitted
- 26 Dec 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- 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 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Compression Anastomosis Procedure for Partial Jejunoileal Anastomosis: Assessing the Viability of an Innovative Metabolic Approach
- ClinicalTrials.gov ID
- NCT07495787
- Acronym / sponsor ID
- 2025/01/EDIT
- Conditions
- Diabete Type 2
- Keywords
- Magnetic Compression Anastomosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- iIDEAS Group Holdings LimitedIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 27 Mar 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.
English, Hindi and Gujarati
Detailed description
Title: Magnetic Compression Anastomosis Procedure for Partial Jejunoileal Anastomosis: Assessing the Viability of an Innovative Metabolic Approach Protocol Number 2025/01/EDIT Trial Type Investigator Initiated Trial This investigator-initiated trial (IIT) is a prospective, single-center, single-arm observation study in patients designed to explore metabolic indicator and procedural outcomes in patients with T2DM. A total of 5 patients with T2DM will be recruited in the study. Following the administration of general anesthesia, surgeon will introduce the ring component of the magnetic compression anastomosis system through an enterotomy. The insertion of the distal ring into the terminal ileum via an enterotomy, positioned approximately 30 cm proximal to the ileocecal valve, utilizing a laparoscopic deployment instrument. The proximal ring is then placed in the proximal jejunum, located around 20 cm (with a variance of ± 10 cm) distal to the ligament of Treitz. Laparoscopic techniques are employed to maneuver the bowel, aligning the proximal and distal magnets for effective magnetic coupling and observing the ring pair mating via intraoperative imaging (fluoroscopy or plain x-ray). This IIT will be conducted in single centre in India by a qualified investigator. It will be initiated after Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
The anticipated timeline for this study is as follows:
- Study Participant Enrollment: 02 months
- Procedure Period: 01 day
- Post procedure care: As suggested by the PI
- Safety and functionality follow-up: 6 weeks, 3 months, 6 months, 9 months
- Additional indications of efficacy follow-up: 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Anastomosis | Experimental | Device: Magnetic Compression Anastomosis |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects will be included in the study if they meet the following criteria:
Key exclusion criteria (30 listed)
- 1. Pregnancy or breastfeeding mothers, or individuals planning to become pregnant in next 9-12 months 2. Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.) 3. Current enrolment in another research study or previous participation within 30 days of enrolment 4. Current history of injected Glucagon Like Peptide 1 (GLP1) 5. American Society of Anesthesiologists (ASA) physical classification level of 4 or greater 6. Hypoglycemia unawareness or a history of severe hypoglycemia (more than 1 severe hypoglycemic event, as defined by need for third-party-assistance, in the last year) 7. Evidence of type 1 diabetes or of pancreatic exhaustion, as indicated by a C peptide fasting level less than 1 or, for type 1 diabetes, based on measurable levels of serum anti-GAD-65 autoantibodies or, at investigator's discretion, based on measurable levels of other T1D-associated autoantibodies 8. History of highly unusual or challenging gastrointestinal tract anatomy ascertained through earlier endoscopic examination or other diagnostic imaging 9. History of (or known to be at prohibitive risk for) any of the following diseases of the small bowel or closely related conditions: Crohn's disease or other inflammatory bowel disease, celiac disease, resection for cancer, or intra-abdominal adhesive disease including intussusception, perforated appendix and Meckel's diverticulum 10. History of small bowel surgery such as small bowel resection 11. Active H. pylori infection (prospective participants with active H. pylori may continue with the screening process if they are treated via medication and re-testing verifies the condition has resolved.) 12. History of chronic or acute pancreatitis 13. Known active hepatitis or active liver disease 14. Symptomatic gallstones or kidney stones or acute cholecystitis
- Subjects will be deemed ineligible to participate if they fulfill any of the following criteria:
- Pregnancy or breastfeeding mothers, or individuals planning to become pregnant in next 9-12 months
- Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.)
- Current enrolment in another research study or previous participation within 30 days of enrolment
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 |
|---|---|---|
| Magnetic Compression AnastomosisThis is an Investigator Initiated trial, prospective, single-center, single-arm observational study in patients with Type II Diabetes Mellitus (T2DM). A total of 5 patients with T2DM will be recruited in the study. Following the administration of general anesthesia, surgeon will introduce the ring component of the magnetic compression anastomosis system through an enterotomy. Laparoscopic techniques are employed to maneuver the bowel, aligning the proximal and distal magnets for effective magnetic coupling and observing the ring pair mating via intraoperative imaging (fluoroscopy or plain x-ray). | Device | Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Anastomosis |
Primary outcome
Placement success rate - ≥ 90% alignment of magnets Passage of magnets without surgical re-intervention Safety
Time frame: Changes in glycosylated hemoglobin A1c (HbA1c) levels will be observed from baseline, 3 months, 6 months, 9 months and at 12 months following the index procedure.
evaluating Placement success rate Passage of magnets without surgical re-intervention Radiological confirmation of patent anastomosis Safety profile To monitor the safety profile of the device by assessing the incidence and severity of procedural and device related complications or adverse events
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 27 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Compression Anastomosis in people with Diabete Type 2, run by iIDEAS Group Holdings Limited at 1 site in India.
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 8 inclusion and 30 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 Purvi A Chavda, MD (8905818034, purvi@curexbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Placement success rate - ≥ 90% alignment of magnets Passage of magnets without surgical re-intervention Safety (time frame: Changes in glycosylated hemoglobin A1c (HbA1c) levels will be observed from baseline, 3 months, 6 months, 9 months and at 12 months following the index procedure.). 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 27 Mar 2026.