A Prospective, Single-Arm, Multi-Center Study of the Metavention Integrated Radio Frequency Denervation System to Improve Glycemic Control in Type 2 Diabetic Subjects

Status: Completed
Location: See all (8) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The objective of this early feasibility study is to evaluate the safety and performance of intravascular hepatic denervation using the Metavention Integrated Radio Frequency Denervation System (iRF System) to improve glycemic control in type 2 diabetes subjects.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 70
Healthy Volunteers: f
View:

• Age ≥22 and ≤70 years old

• Type 2 diabetes diagnosis meeting the following criteria:

‣ HbA1c \> 7.0% and ≤ 9.0% (53 mmol/mol - 75 mmol/mol), AND

⁃ On at least two anti-diabetic medications; one at the highest tolerated dose with no changes in medication dose in the 12 weeks prior to the first screening visit

• Waist circumference ≥102 cm (male) and ≥88cm (female)

• Diagnosis of hypertension: SBP ≥140mmHg OR SBP ≥130mmHg on hypertension medication(s)

• Documented status of stable lifestyle modifications

• Women of childbearing potential (WOCBP) must be using at least one acceptable method of contraception throughout the study

Locations
United States
Alabama
Cardiology, P.C.
Birmingham
California
Stanford University Medical Center
Stanford
Florida
AdventHealth Translational Research Institute
Orlando
Illinois
Prairie Education & Research Cooperative (PERC)
Springfield
Minnesota
Metropolitan Cardiology Consultants
Coon Rapids
Oklahoma
South Oklahoma Heart Research, LLC
Oklahoma City
Pennsylvania
UPMC Pinnacle
Harrisburg
Texas
Soltero Cardiovascular Research Center
Dallas
Time Frame
Start Date: 2020-07-28
Completion Date: 2022-12-19
Participants
Target number of participants: 15
Treatments
Experimental: Hepatic Denervation
Related Therapeutic Areas
Sponsors
Leads: Metavention

This content was sourced from clinicaltrials.gov

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