Self Forming Magnetic (SFM) Anastomosis System for Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Obesity+1 MoreSelf Forming Magnetic (SFM) Anastomosis System - Device
Eligibility
19 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study how well weight loss and different metabolic indicators improve in people with obesity.

Eligible Conditions
  • Obesity
  • Type 2 Diabetes

Treatment Effectiveness

Study Objectives

1 Primary · 14 Secondary · Reporting Duration: 12 months

12 months
Absolute Weight Loss Measures
Albumin - Nutritional Status
BMI - Weight Loss Measures
Blood Pressure Changes
Diabetes Medication Dosage and Frequency Changes
Diabetes Remission and/or Improvements
Excess Weight Loss Measures
Fasting Glucose
Hemoglobin A1c
Liver Changes using Fibroscan
Nutritional Status
Other Weight Loss Measures
Percent Responders
Serum Lipids
Weight Loss

Trial Safety

Trial Design

1 Treatment Group

Device Placement
1 of 1

Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: Self Forming Magnetic (SFM) Anastomosis System · No Placebo Group · N/A

Device Placement
Device
Experimental Group · 1 Intervention: Self Forming Magnetic (SFM) Anastomosis System · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

GI Windows, Inc.Lead Sponsor
5 Previous Clinical Trials
465 Total Patients Enrolled
1 Trials studying Obesity
15 Patients Enrolled for Obesity

Eligibility Criteria

Age 19 - 65 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have type 2 diabetes and have been diagnosed with it for at least 6 months, but less than 10 years.