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Safety and Initial Performance of the DiaGone Device on Type 2 Diabetes Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03390322
Recruitment Status : Recruiting
First Posted : January 4, 2018
Last Update Posted : February 16, 2021
Sponsor:
Information provided by (Responsible Party):
Digma Medical Ltd.

Study Description
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Brief Summary:
This is a multi-center, prospective, open label study of the Duodenal Glycemic Control™ procedure on type 2 diabetes patients sub-optimally controlled, to examine the safety and initial performance of the DiaGone™ system.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Device: DiaGone™ Not Applicable

Detailed Description:

This study is a multi-center, prospective, open label trial of type 2 diabetes patients sub-optimally controlled on at least one oral anti-diabetic medication.

Subjects who meet all inclusion and exclusion criteria after screening are hospitalized and go through the Duodenal Glycemic Control™ treatment.

Duodenal Glycemic Control™ treatment is conducted by a gastroenterologist, in an endoscopic suite, with an off-the-shelf endoscope, using the DiaGone™ system.

Patients are followed for 6 months for AE and SAE. Patients are followed for 12 months for glycemic control parameters.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DiaGone™ First in Human (FIH) Study - Safety and Performance of the DiaGone™ Device for the Treatment of Type 2 Diabetes
Actual Study Start Date : July 28, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Duodenal Glycemic Control™ Device: DiaGone™
Duodenal Glycemic Control™ using the DiaGone™ system


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of procedure related SAEs. [ Time Frame: 7 days ]
  2. Incidence of procedure related SAEs. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change to Fasting Glucose levels [ Time Frame: 12 months ]
  2. Change to Post Prandial Glucose levels [ Time Frame: 12 months ]
  3. Change to HbA1c levels [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who are ≥ 18 years and ≤ 75 years of age.
  • HbA1c at 7.5%-12%
  • On oral glucose lowering drugs in a stable medication regimen
  • Fasting plasma glucose level at ≥125mg/dL
  • BMI 25-40 Kg/m2

Exclusion Criteria:

  • Diagnosed Type I diabetes
  • Serum C peptide <1ng/ml
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390322


Contacts
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Contact: Chen Botvin Moshe +972-(0)54-6703737 chenbm@digmamedical.com

Locations
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Czechia
IKEM Recruiting
Prague, Czechia
Contact: Gabriela Petranova    +420 261 365 154    Gabriela.Petranova@ikem.cz   
Principal Investigator: Marek Benes, MD         
Israel
Shaarei Tzedek Not yet recruiting
Jerusalem, Israel
Contact: Yael Lagemi       yaelagemi@szmc.org.il   
Principal Investigator: Eran Goldin, Prof, MD         
Spain
Barcelona Clinical Hospital Not yet recruiting
Barcelona, Spain
Contact: Joseph Vidal Cortada       jovidal@clinic.cat   
Principal Investigator: Joseph Vidal Cortada, MD         
Ramón y Cajal Insitute of Health Research Not yet recruiting
Madrid, Spain
Contact: Chen BotvinMoshe       chenbm@digmamedical.com   
Principal Investigator: Enrique Vazques, MD         
Sponsors and Collaborators
Digma Medical Ltd.
More Information
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Additional Information:

Publications:

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Responsible Party: Digma Medical Ltd.
ClinicalTrials.gov Identifier: NCT03390322    
Other Study ID Numbers: CLD-008
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases