An interventional study of NROT1 in Morbid Obesity, sponsored by Yeditepe University. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-06-22.
Sponsored by Yeditepe University · Not applicable, Interventional, and Treatment
The present study relates to apparatus and methods that can be applied using non-invasive techniques for effectively reducing nutrient absorption in the small intestines of obese people.
Obesity is a worldwide health problem which may be further worsened by global Corona virus (COVID-19) pandemic. It may cause social, psychological disorders and chronic diseases such as diabetes and cardiac problems.
Surgical and existing non-surgical (e.g., intragastric balloon placement) procedures are well established procedures to cope with the morbid obesity problem. The principle of using these procedures is based on reducing the surface area available for absorption in the stomach or in small intestine, so that weight loss is gradually accomplished.
Recent bariatric surgery procedures (a more complete description of which can be found for example on the website of the American Society for Bariatric Surgery at http://www.asbs.org) involve alteration of a patient's digestive tract including various reversible and malabsorptive bypass procedures such as jejuno-ileal bypass, gastric bypass and Roux-en-Y gastric bypass, or by irreversible gastric sleeve (restrictive) procedures.
In non-surgical intragastric balloon (IGB) placement procedures, the volume of the space occupying device (balloon) prevents the ingestion of food into the stomach, reducing the desire for food.
Most known complications of IGBs are nausea, vomiting, and discomfort, during and/or shortly after their insertion and removal. Blockage risk of the exit of the stomach (pylori) due to squeezing-pushing action of the stomach is another issue with IGBs.
On April 27, 2020, the U.S. Food and Drug Administration (FDA) released an update on the potential risks of over-inflation (spontaneous hyperinflation), acute pancreatitis, and deaths in patients with some liquid-filled IGBs. Hyperinflation involves the spontaneous filling of IGBs with additional air or liquid while the balloon is in the stomach, this usually requires IGB removal. On the other hand, the mechanism of acute pancreatitis development could be related to pressure from the IGB and distended stomach causing direct injury to the pancreatic parenchyma, compression of the pancreatic duct, and/or indirect pancreatic injury through duodenal obstruction.
All of these critical observations mentioned above show that there is a need for a transorally placed device which can be easily inserted into and removed from the gastrointestinal tract, does not migrate, minimize complications, well tolerated and less costly.
The present study aims to provide a gastrointestinal implant device which includes a solid part for placement into a small intestine so that it reduces absorption of nutrients and particularly fats through the small intestine. This can be more effective weight losing procedure than IGB application alone in stomach, as nutrients and fat intake can be reduced using intestinal implant device.
Transorally placed implant device can be easily inserted into and removed from the gastrointestinal tract, does not migrate, and costs less.
While existing non-surgical weight losing devices induce satiation, hence reduce the frequency and amount of eating, present invention does not limit them, since the operational principle of the present study is neither based on a space occupying type nor a sleeve type implant.
SCIENTIFIC BACKGROUND
Based on this fundamental physiological information, in this study, implant piece placed into the small intestine is anchored either in the stomach or in the oral cavity (dental anchoring) with a biocompatible thread, and the small intestine segments are accumulated in the proximal end of the small intestine in the manner of an accordion in the region where implant device is floating, hence shortening its length and reducing the overall small intestinal absorption area.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 20 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Yeditepe University is the lead sponsor of 127 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
Intestinal device placement in subjects and their follow up
Device: NROT1
Dental anchored intestinal placement of obesity treatment device with endoscopic intervention
Change of weight in subjects after 6 Months of intestinal device placement
The weight of each subject will be measured and recorded at the time of intestinal device placement and after 6 months of the placement. Then, statistical analysis will be carried out.
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Yeditepe University