Type2 Diabetes MellitusNEUJIA 1ANCT03675074
Neujia Anastomosis for Treatment of Obesity and Type II Diabetes
A study testing Neujia in people with Type2 Diabetes Mellitus and Obesity, run by Neurotronic, Inc..
Trial summary
This prospective, multicenter, open label, single arm study will enroll subjects presenting with obesity and inadequately controlled type II diabetes (T2DM). A dual path jejunoileal side-to-side anastomosis is endoscopically created using the Neujia device. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Type2 Diabetes Mellitus, Obesity
- What is being tested?
- Neujia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 12 Sep 2018to 21 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 22 and < 65 years, estimated life expectancy ≥ 2 years;
- BMI ≥ 30 and < 40 kg/m2;
- HbA1c ≥ 8.0 and ≤ 11%;
- Fasting Glucose (FG) ≥ 126 mg/dL;
- Under active medical care with ≥ 6-months treatment on ≥ 2 anti-diabetic medications;
- T2DM diagnosed ≤ 10 years prior to enrollment;
Show all 30Show fewer
- Non-fasting random or stimulated C-peptide ≥ 2 ng/mL (660 pmol/l);
- Willing and able to provide informed consent, comply, and be geographically stable
- Major Exclusion Criteria:
- Type I diabetes, positive autoantibodies to glutamic acid decarboxylase 65 (GAD65), secondary diabetes;
- Hypoglycemia unawareness or serious hypoglycemia with loss of consciousness or confusion sufficient to prevent self-treatment in last 6 months;
- Any condition for which endoscopy or colonoscopy would be contraindicated;
- Any condition for which general anesthesia would be contraindicated;
- Congenital or acquired anomalies of the gastrointestinal (GI) tract, abnormal GI anatomical finding, or anatomy precluding deep small bowel enteroscopy sufficient to prevent endoscopic advancement to the target treatment site;
- Previous laparoscopic or open abdominal or pelvic surgery (except for prior caesarian section or laparoscopic cholecystectomy, which are allowed);
- History of abdominal or pelvic infection or disease or procedures that may have resulted in abdominal adhesions;
- Known history of autoimmune bowel disease or chronic inflammatory bowel disease (IBD);
- Active inflammatory gastrointestinal disease (e.g., pancreatitis, hepatitis) or systemic infection (e.g., tuberculosis, malaria);
- Known history of chronic liver disease (except nonalcoholic steatohepatitis (NASH)/ nonalcoholic fatty liver disease (NAFLD)), hepatic cirrhosis, or current transaminase/alkaline phosphatase elevation above three times the upper limit of normal (in the absence of NASH/NAFLD);
- Severe or unstable pulmonary or circulatory comorbidities posing risks to the patient that may confound the results of the study in investigator's judgment;
- History of cardiovascular event within last 6 months or with chronic sequela;
- Uncontrolled hypertension with systolic blood pressure (SBP) over 160 mmHg or diastolic blood pressure (DBP) over 110 mmHg;
- Estimated glomerular filtration rate (eGFR) < 30 mL/min per 1.73 m2;
- Currently taking pre-meal, bolus, or premixed insulin (patients on basal insulin only are allowed);
- Malignancy that required therapy in the last 5 years (unless cancer only in situ e.g. basal cell carcinoma (BCC)), history of organ transplantation, or currently on immune-suppressive, chemotherapeutic, or radiation therapy;
- History of vasculopathy, coagulopathy, or currently on anti-coagulation therapy;
- Abnormal wound healing, e.g., human immunodeficiency virus (HIV), corticosteroid, or immunosuppressive agent use;
- Planned magnetic resonance imaging (MRI) or any condition for which MRI is likely to be indicated within 3 months;
- Pregnant or planning on becoming pregnant within 12 months of procedure;\
- Known serious or uncontrolled psychiatric disease, eating disorder, or active alcohol or drug addiction.
Who cannot join
None listed.
About this study
Official title: Single Arm Study of Neurotronic Fully Endoscopic Jejunoileal Side-to-side Anastomosis for Treatment of Obesity and Type II Diabetes: The Neujia 1A Trial
This prospective, multicenter, open label, single arm study will enroll subjects presenting with obesity and inadequately controlled type II diabetes (T2DM). A dual path jejunoileal side-to-side anastomosis is endoscopically created using the Neujia device. Subjects are followed for 12 months and annually thereafter for up to 5 years to assess change in metabolic parameters, medications, weight, and adverse events.
Read the detailed description
For many obese diabetics, medical treatment and lifestyle modification fail to provide acceptable glucose levels or durable weight loss. Bariatric surgical procedures have been proven to provide better glycemic control and to improve life expectancy and quality of life. But these are invasive procedures with significant complications, and notwithstanding the strong clinical evidence and consensus guidance, less than 2% of patients who would benefit from bariatric surgery choose to undergo the invasive procedures. There is therefore a significant unmet clinical need for metabolic/bariatric therapies that result in durable improvement in glycemic control, decreased anti-diabetic medication requirements, and weight loss, with fewer and less severe complications than invasive bariatric surgery.
Human clinical data suggests that partial diversion through a side-to-side jejunoileal anastomosis results in an absolute decrease in HbA1c of 1.9 to 3.6 percentage points and a decrease in total weight of 9.6 to 14.6% at 12 months. Although these studies used other methods, they provide good evidence that the anastomosis created by Neujia should be expected to safely improve glycemic control.
A minimally invasive anastomosis device (Neujia) and endoscopic delivery system have been developed to create a side-to-side jejunoileal anastomosis. One device is deployed in the jejunum, approximately 30 to 100 cm distal to the ligament of Treitz, and the other in the ileum, approximately 30 to 100 cm proximal to the ileocecal valve. The devices are mated under endoscopic guidance with fluoroscopic visualization and create a compression anastomosis. Neujia has the potential to provide a fully endoscopic, incisionless procedure that achieves durable weight loss and glycemic control without the risks of bariatric surgery. The proposed single arm study is designed to assess the feasibility and safety and efficacy of the Neujia device when used to treat T2DM and obesity. Subjects are followed for 12 months and annually thereafter for up to 5 years to assess change in metabolic parameters, medications, weight, and adverse events.
- Conditions
- Type2 Diabetes Mellitus, Obesity
- Being tested
- Neujia
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeujiaDevice
Neujia devices endoscopically deployed for jejunoileal compression anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | A dual path jejunoileal side-to-side anastomosis is endoscopically created using the Neujia device. Receives: Device: Neujia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Measured: 6 months
Secondary outcomes (8)
Technical and Procedural Success
Successful endoscopic deployment without procedural serious adverse events
Measured: 1 day
Composite Safety: percent of subjects with Freedom from bowel perforation, anastomotic leak, stricture, obstruction, and prolonged dumping syndrome (>90 days)
Measured: 1, 3, 6, 9, 12, 24, 36, 48, 60 months
Reversal or Revision Rate
Measured: 1, 3, 6, 9, 12, 24, 36, 48, 60 months
Change in HbA1c
Measured: 1, 3, 6, 9, 12, 24, 36, 48, 60 months
Change in diabetic medications
Change in the number of prescribed anti-diabetic medications and dosage from subject's medications at baseline
Measured: 1, 3, 6, 9, 12, 24, 36, 48, 60 months
Percentage with HbA1c ≤ 6.5% or ≤ 7.0%, by medication status
Measured: 1, 3, 6, 9, 12, 24, 36, 48, 60 months
Change in fasting plasma glucose (FG)
Measured: 1, 3, 6, 9, 12, 24, 36, 48, 60 months
Change in weight
Measured: 1, 3, 6, 9, 12, 24, 36, 48, 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start12 Sep 2018
- Primary completion4 Dec 2018
- Study completion21 Jan 2019
Why it stopped: Deployment site not obtained in 5 patients with endoscopic screening and intent-to-treat. No devices implanted and no AEs through 30days.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 Diabetes MellitusStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurotronic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Irving Waxman, MD, Principal investigator, Center Director of The Center for Endoscopic Research and Therapeutics (CERT), University of Chicago Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675074
- Sponsor's protocol ID
- 450 - NEUJIA 1A Study CIP
- Acronym
- NEUJIA 1A
- Status last verified
- Jan 2019
- First submitted
- 11 Sep 2018
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm Study of Neurotronic Fully Endoscopic Jejunoileal Side-to-side Anastomosis for Treatment of Obesity and Type II Diabetes: The Neujia 1A Trial
- ClinicalTrials.gov ID
- NCT03675074
- Acronym / sponsor ID
- NEUJIA 1A / 450 - NEUJIA 1A Study CIP
- Conditions
- Type2 Diabetes Mellitus, Obesity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Deployment site not obtained in 5 patients with endoscopic screening and intent-to-treat. No devices implanted and no AEs through 30days.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Neurotronic, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Sep 2018 (actual)
- Primary completion
- 4 Dec 2018 (actual)
- Study completion
- 21 Jan 2019 (actual)
- First posted
- 18 Sep 2018 (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.
This prospective, multicenter, open label, single arm study will enroll subjects presenting with obesity and inadequately controlled type II diabetes (T2DM). A dual path jejunoileal side-to-side anastomosis is endoscopically created using the Neujia device. Subjects are followed for 12 months and annually thereafter for up to 5 years to assess change in metabolic parameters, medications, weight, and adverse events.
Detailed description
For many obese diabetics, medical treatment and lifestyle modification fail to provide acceptable glucose levels or durable weight loss. Bariatric surgical procedures have been proven to provide better glycemic control and to improve life expectancy and quality of life. But these are invasive procedures with significant complications, and notwithstanding the strong clinical evidence and consensus guidance, less than 2% of patients who would benefit from bariatric surgery choose to undergo the invasive procedures. There is therefore a significant unmet clinical need for metabolic/bariatric therapies that result in durable improvement in glycemic control, decreased anti-diabetic medication requirements, and weight loss, with fewer and less severe complications than invasive bariatric surgery.
Human clinical data suggests that partial diversion through a side-to-side jejunoileal anastomosis results in an absolute decrease in HbA1c of 1.9 to 3.6 percentage points and a decrease in total weight of 9.6 to 14.6% at 12 months. Although these studies used other methods, they provide good evidence that the anastomosis created by Neujia should be expected to safely improve glycemic control.
A minimally invasive anastomosis device (Neujia) and endoscopic delivery system have been developed to create a side-to-side jejunoileal anastomosis. One device is deployed in the jejunum, approximately 30 to 100 cm distal to the ligament of Treitz, and the other in the ileum, approximately 30 to 100 cm proximal to the ileocecal valve. The devices are mated under endoscopic guidance with fluoroscopic visualization and create a compression anastomosis. Neujia has the potential to provide a fully endoscopic, incisionless procedure that achieves durable weight loss and glycemic control without the risks of bariatric surgery. The proposed single arm study is designed to assess the feasibility and safety and efficacy of the Neujia device when used to treat T2DM and obesity. Subjects are followed for 12 months and annually thereafter for up to 5 years to assess change in metabolic parameters, medications, weight, and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: NeujiaA dual path jejunoileal side-to-side anastomosis is endoscopically created using the Neujia device. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Age ≥ 22 and < 65 years, estimated life expectancy ≥ 2 years;
- BMI ≥ 30 and < 40 kg/m2;
- HbA1c ≥ 8.0 and ≤ 11%;
- Fasting Glucose (FG) ≥ 126 mg/dL;
- Under active medical care with ≥ 6-months treatment on ≥ 2 anti-diabetic medications;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| NeujiaNeujia devices endoscopically deployed for jejunoileal compression anastomosis | Device | Treatment |
Primary outcome
Change in HbA1c
Time frame: 6 months
8 secondary outcomes
Technical and Procedural Success
Time frame: 1 day
Composite Safety: percent of subjects with Freedom from bowel perforation, anastomotic leak, stricture, obstruction, and prolonged dumping syndrome (>90 days)
Time frame: 1, 3, 6, 9, 12, 24, 36, 48, 60 months
Reversal or Revision Rate
Time frame: 1, 3, 6, 9, 12, 24, 36, 48, 60 months
Change in HbA1c
Time frame: 1, 3, 6, 9, 12, 24, 36, 48, 60 months
Change in diabetic medications
Time frame: 1, 3, 6, 9, 12, 24, 36, 48, 60 months
Percentage with HbA1c ≤ 6.5% or ≤ 7.0%, by medication status
Time frame: 1, 3, 6, 9, 12, 24, 36, 48, 60 months
Change in fasting plasma glucose (FG)
Time frame: 1, 3, 6, 9, 12, 24, 36, 48, 60 months
Change in weight
Time frame: 1, 3, 6, 9, 12, 24, 36, 48, 60 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
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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. This study is not recruiting at the moment.
Irving Waxman, MD principal investigator
Center Director of The Center for Endoscopic Research and Therapeutics (CERT), University of Chicago Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Neujia in people with Type2 Diabetes Mellitus and Obesity, run by Neurotronic, 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 30 inclusion and 0 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: withdrawn, as of the sponsor's last update on 4 Feb 2019. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: 6 months). 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 4 Feb 2019.