Research Study

C-40000

Study Status: Active - Open to Enrollment

Study Name: C-40000

Study Focus: A1c and Glucose

 

Study Contact: To learn more, please call 1-877-854-8475 or fill out the Contact us form.

Study Purpose: The purpose of this study is to learn more about the use of the RevitaTM System for the treatment of Type 2 diabetes.

To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if you meet the following criteria:

  • 28-65 years of age
  • BMI 28-40 kg/m2
  • Type II Diabetes (at least three years)
  • Prescribed with 2 OADs, one of them Metformin

Study Duration: up to 60 weeks

Study Commitment:

  • 3 Screening visits
  • Up to 11 Outpatient visits (including procedure visit)
  • Up to 10 Phone calls

Study Procedures:

  • Physical exam, vital signs, height, and weight, EKG, fasting labs
  • IV insertion
  • Multiple blood draws
  • Phone calls
  • Urine Screen
  • Pregnancy Test
  • MRI
  • Endoscopy (Duodenal Mucosal Resurfacing [DMR] or Sham procedure)
  • Biopsy during endoscopy at week 24 (only DMR patients)
  • Questionnaires
  • Diary completion

Compensation offered up to $ 2,325 to cover visit related expenses

This study is being conducted under the direction of Dr. Steven Smith at 301 East Princeton Street, Orlando, Florida 32804.