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Clinical Trials/CTRI/2018/10/015928
CTRI/2018/10/015928
Not yet recruiting
未知

A Feasibility Study to Evaluate the Safety and Performance of the EndoSleeveâ?¢ System in Obese patients with or without Type 2 Diabetes Mellitus - ES01

Metamodix Inc0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: E70-E88- Metabolic disordersHealth Condition 2: E65-E68- Overweight, obesity and other hyperalimentation

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: E70-E88- Metabolic disordersHealth Condition 2: E65-E68- Overweight, obesity and other hyperalimentation
Sponsor
Metamodix Inc
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Metamodix Inc

Eligibility Criteria

Inclusion Criteria

  • •1\. Age \> 18 years and \< 65 years â?? Male or Female
  • •2\. BMI \> 27\.5 kg/m2 and \< 40 kg/m2
  • •3\. Obese non\-diabetes patients or Obese Type 2 Diabetes patients with HbA1c at screening \> 7\.0 and \< 10\.0% and being treated by diet or oral anti\-diabetes agents (Metformin, DPP\-4i, SU or TZD)
  • •4\. Patient or legally authorized representative of the patient is willing and able to sign an IEC approved informed consent form and agrees to comply with study requirements

Exclusion Criteria

  • •1\. Patients requiring injectable treatments (insulin, GLP\-1R agonists)
  • •2\. Patients with Type 1 Diabetes Mellitus or having any history of ketoacidosis
  • •3\. Patients with iron deficiency and iron deficiency anemia
  • •4\. Patients requiring anticoagulation therapy
  • •5\. Patients with inflammatory bowel disease or condition of the gastrointestinal tract, such as ulcers or Crohnâ??s disease
  • •6\. Patients with pancreatitis or other serious organic conditions
  • •7\. Patients with known gallstones prior to implant
  • •8\. Patients with known infection at the time of implant
  • •9\. Patients with severe coagulopathy, upper gastro\-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
  • •10\. Patients with symptomatic coronary artery disease or pulmonary dysfunction

Outcomes

Primary Outcomes

Not specified

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