Study of Duodenal Mucosal RF Vapor Ablation in Subjects With Type-2 Diabetes Mellitus

Diabetes Mellitus Type 2 Clinical Trial

— STEAM T-2DM  

Official title:

A Pilot Human Investigation of the Safety, Tolerability and Effectiveness of the Aqua Medical Circumferential RF Vapor (RFV) Ablation System for Duodenal Mucosal Ablation for the Management of Type-2 Diabetes Mellitus (STEAM T-2DM Pilot)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05887635
• Other study ID #: CLD-1021
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2, 2023
• Est. completion date: October 2024

Study information

• Verified date: March 2024
• Source: Aqua Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical study is to test the hypothesis that RF vapor ablation of the duodenal mucosa will result in improvement in glycemic parameters, without complications (bleeding/ stricture / perforation).

The main aims of the study are :

1. Evaluate the safety of the device and procedure based on the reported adverse events that occur.

2. Evaluate the effectiveness of the device and procedure by comparing change in HbA1c from baseline to 168 days post procedure.

3. Evaluate device tolerability based on pain scores reported by patients. The subject population for this study are adults (18-65 years of age) with type-2 diabetes mellitus. Study participation is 6 months for each patient.

The study is comprised of 4 phases: Screening, Run-in, RF Vapor ablation procedure, and Post-vapor ablation follow-up (up to 168 days).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: October 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Men and non-pregnant women 18-65 years of age

2. Diagnosed with T2D for at least 3 years and less than or equal to 10 years

3. HbA1C of 7.5 - 10% (59-86 mmol/mol)

4. BMI = 24 and = 40 kg/m2

5. On a minimum of 1 stable oral anti-diabetic medications with no changes in medication in the previous 3 months prior to study entry Note: For subjects on sulfonylurea (SU) glucose-lowering drugs for diabetes, the only SUs permitted in the study will be glipizide or glimepiride, and their doses below half maximum labeled dosing will not be an exclusion for study entry. Subjects unwilling to reduce the dose of SU at the run-in period will be excluded.

6. Agrees to use an additional glucose-lowering treatment (e.g., liraglutide, other OAD with the exception of glyburide), if recommended by the study Investigator in case of persistent hyperglycemia.

7. Able to comply with study requirements and understand and sign the Informed Consent Form

Exclusion Criteria:

1. Diagnosis of Type-1 Diabetes

2. History of diabetic ketoacidosis or hyperosmolar nonketotic coma.

3. Probable insulin production failure, defined as fasting C Peptide serum <1 ng/mL (333pmol/l).

4. Previous use of any types of insulin for >1 month (at any time, except for treatment of gestational diabetes).

5. Current use of injectable medications for diabetes (insulin, GLP-1RA).

6. Current use of glyburide, a sulfonylurea (SU) glucose-lowering drug for diabetes.

7. History of severe hypoglycemia (more than 1 severe hypoglycemic event, as defined by need for third-party assistance, in the last year).

8. Known autoimmune disease, including but not limited to celiac disease, duodenal Crohn disease or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other systemic autoimmune connective tissue disorder.

9. Previous GI surgery that could limit treatment of the duodenum such as Billroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions. (Prior laparoscopic sleeve gastrectomy (LSG) will not be an exclusion)

10. History of chronic or acute pancreatitis.

11. History of diabetic gastroparesis.

12. Known active hepatitis or active liver disease.

13. Acute gastrointestinal illness in the previous 7 days.

14. Known history of severe irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease.

15. Known history of a structural or functional disorder of the esophagus that may impede passage of the device through the gastrointestinal tract or increase risk of esophageal damage during an endoscopic procedure, including moderate-severe (Grade C or D) esophagitis, dysphagia due to achalasia or stricture/stenosis, esophageal varices, esophageal perforation, or any other disorder of the esophagus.

16. Upper gastrointestinal conditions such as active ulcers, polyps, varices, strictures, congenital or acquired duodenal telangiectasia

17. Current use of anticoagulation therapy (such as warfarin) that cannot be discontinued for 7 days before and 14 days after the procedure.

18. Current use of P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) that cannot be discontinued for 14 days before and 14 days after the procedure.

19. Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) during treatment through 4 weeks following the procedure. Use of acetaminophen and low dose aspirin is allowed.

20. Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 12 weeks prior to the baseline visit.

21. Use of drugs known to affect GI motility (e.g. Metoclopramide)

22. Use of weight loss medications such as Sibutramine (e.g. Meridia), Orlistat (e.g. Xenical), Phentermine or over-the-counter weight loss medications (prescription medication)

23. Currently taking, or unable to stop taking dietary supplements or herbal agents, including vitamin C or multivitamins containing vitamin C at >500 mg per day, multivitamins containing biotin (vitamin B7), and supplements for hair, skin, and nail growth. Multivitamins not containing biotin are permitted.

24. Significant cardiovascular disease, including known history of valvular disease, or myocardial infarction, heart failure, transient ischemic attack, or stroke within 6 months prior to the Screening Visit.

25. Mean of 3 separate blood pressure measurements >180 mmHg (systolic) or >100 mmHg (diastolic).

26. Estimated glomerular filtration rate (eGFR) = 60 ml/min/1.73m2 (estimated by MDRD).

27. Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months, who have clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the participant a poor candidate for clinical trial participation in the opinion of the investigator.

28. Active illicit substance abuse or alcoholism (>2 drinks/day regularly)

29. Active malignancy within the last 5 years (excluding non-melanoma skin cancers)

30. Women breastfeeding

31. Participating in another ongoing clinical trial of an investigational drug or device.

32. Any other mental or physical condition which, in the opinion of the study investigator, makes the participant a poor candidate for clinical trial participation.

33. Critically ill or has a life expectancy <3 years

34. Use of heart pacemaker or other electronic device implants

35. General contraindications to deep or conscious sedation, general anesthesia, high risk as determined by anesthesiologist (e.g., ASA score 4 or higher), or contraindications to upper GI endoscopy.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Device:
• RF Vapor Ablation
RF Vapor ablation of the duodenum

Locations

Country	Name	City	State
Chile	Clinica Colonial	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Aqua Medical, Inc.

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety endpoint	Number of subjects with reported device or procedure related SAEs or UADEs.	1 month
Primary	Efficacy endpoint	Change in HbA1c from baseline to 168 days post procedure	6 months
Primary	Tolerability Endpoint:	Descriptive statistics on Visual Analogue Scale(VAS) pain scores	7 days
Secondary	Change in HbA1c at 84 and 168 days post procedure	Change in HbA1c (from baseline) at 84 and 168 days post procedure will be analyzed	168 days
Secondary	Change in HbA1c by visit over time	Change in HbA1c by visit over time, comparing with baseline	168 days
Secondary	Change in FPG from baseline to 84 and 168 days post procedure	Change in FPG from baseline to 84 and 168 days post procedure	168 days
Secondary	Change in FPG change by visit over time (168 days post procedure)	Change in FPG change by visit over time (168 days post procedure)	168 days
Secondary	Proportion of ablation-treated subjects with an HbA1c improvement from baseline at 168 days	Proportion of ablation-treated subjects with an HbA1c improvement from baseline at 168 days	168 days
Secondary	Changes in HOMA-IR by visit over time (168 days post procedure).	Changes in HOMA-IR by visit over time (168 days post procedure) from baseline	168 days
Secondary	Change in UACR from baseline to 24 weeks post procedure	Change in UACR from baseline to 24 weeks post procedure	24 weeks
Secondary	Change in ALT and AST from baseline to 24 weeks post procedure.	Change in ALT and AST from baseline to 24 weeks post procedure.	24 weeks