Clinical trial NCT05420506: Nonsurgical Reversible Obesity Treatment (NROT1)
Official title: Treatment of Obesity Without Surgical Intervention by Reversible Reduction of the Small Intestinal Absorption Area
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Morbid Obesity
Keywords: obesity treatment
non-surgical
small intestine
reversible
Lead sponsor: Yeditepe University
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

1. All orally ingested foods with caloric value are absorbed from the small intestine, and especially from the proximal small intestine, then pass into the blood. Colon provides only the absorption of fluid and electrolytes.
2. As the length of the small intestine is shortened, the intestinal absorption area for the foods with caloric value will decrease, so even if the patient continues to eat, he or she does not gain weight, on the contrary, he or she loses weight.
3. When the orally ingested foods pass through the stomach and duodenum and then enter into the small intestine, they are pushed from proximal to distal intestine by segmental contraction and relaxation movements called peristaltic movements. During these movements, if the food remains stable or stuck in a certain intestinal region, the small intestine segments gather into the proximal region of the intestine and try to push the food to distal end of small intestine by making more severe peristaltic movements. Meanwhile, the length of the small intestine shortens, hence the overall small intestinal absorption area decreases.

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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of morbid obesity
2. Age limits: 18-65 years
3. No history of gastrointestinal surgery
4. Agreement for voluntary participation in the study

Exclusion Criteria:

1. Presence of obesity that is not at the morbid level
2. Those who do not accept to participate in the study
3. Those who have an obstacle to endoscopic intervention
4. Presence of a history of gastrointestinal surgery

Primary outcomes:
measure: Change of weight in subjects after 6 Months of intestinal device placement
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Yeditepe University
name: Erhan Aysan, M.D.
role: PRINCIPAL_INVESTIGATOR
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