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 : January 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Device: DiaGone™||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||September 2018|
|Estimated Study Completion Date :||March 2019|
|Experimental: Duodenal Glycemic Control™||
Duodenal Glycemic Control™ using the DiaGone™ system
- Incidence of procedure related SAEs. [ Time Frame: 7 days ]
- Incidence of procedure related SAEs. [ Time Frame: 6 months ]
- Change to Fasting Glucose levels [ Time Frame: 12 months ]
- Change to Post Prandial Glucose levels [ Time Frame: 12 months ]
- Change to HbA1c levels [ Time Frame: 12 months ]
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
|Contact: Chen Botvin Moshe||+972-(0)firstname.lastname@example.org|
|Contact: Gabriela Petranova +420 261 365 154 Gabriela.Petranova@ikem.cz|
|Principal Investigator: Marek Benes, MD|
|Shaarei Tzedek||Not yet recruiting|
|Contact: Yael Lagemi email@example.com|
|Principal Investigator: Eran Goldin, Prof, MD|
|Barcelona Clinical Hospital||Not yet recruiting|
|Contact: Joseph Vidal Cortada firstname.lastname@example.org|
|Principal Investigator: Joseph Vidal Cortada, MD|
|Ramón y Cajal Insitute of Health Research||Not yet recruiting|
|Contact: Chen BotvinMoshe email@example.com|
|Principal Investigator: Enrique Vazques, MD|