Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
20 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-12-31
Study Completion Date
2024-06-30
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Morbid Obesity
Study Design
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Allocation Method
NA
Intervention Model
SEQUENTIAL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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NROT1
Intestinal device placement in subjects and their follow up
Group Type
EXPERIMENTAL
NROT1
Intervention Type
DEVICE
Dental anchored intestinal placement of obesity treatment device with endoscopic intervention
Interventions
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NROT1
Dental anchored intestinal placement of obesity treatment device with endoscopic intervention
Intervention Type
DEVICE
Eligibility Criteria
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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
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
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
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Yeditepe University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Erhan Aysan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Yeditepe University
Central Contacts
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References
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Ng M, Fleming T, Robinson M, Thomson B, Graetz N, Margono C, Mullany EC, Biryukov S, Abbafati C, Abera SF, Abraham JP, Abu-Rmeileh NM, Achoki T, AlBuhairan FS, Alemu ZA, Alfonso R, Ali MK, Ali R, Guzman NA, Ammar W, Anwari P, Banerjee A, Barquera S, Basu S, Bennett DA, Bhutta Z, Blore J, Cabral N, Nonato IC, Chang JC, Chowdhury R, Courville KJ, Criqui MH, Cundiff DK, Dabhadkar KC, Dandona L, Davis A, Dayama A, Dharmaratne SD, Ding EL, Durrani AM, Esteghamati A, Farzadfar F, Fay DF, Feigin VL, Flaxman A, Forouzanfar MH, Goto A, Green MA, Gupta R, Hafezi-Nejad N, Hankey GJ, Harewood HC, Havmoeller R, Hay S, Hernandez L, Husseini A, Idrisov BT, Ikeda N, Islami F, Jahangir E, Jassal SK, Jee SH, Jeffreys M, Jonas JB, Kabagambe EK, Khalifa SE, Kengne AP, Khader YS, Khang YH, Kim D, Kimokoti RW, Kinge JM, Kokubo Y, Kosen S, Kwan G, Lai T, Leinsalu M, Li Y, Liang X, Liu S, Logroscino G, Lotufo PA, Lu Y, Ma J, Mainoo NK, Mensah GA, Merriman TR, Mokdad AH, Moschandreas J, Naghavi M, Naheed A, Nand D, Narayan KM, Nelson EL, Neuhouser ML, Nisar MI, Ohkubo T, Oti SO, Pedroza A, Prabhakaran D, Roy N, Sampson U, Seo H, Sepanlou SG, Shibuya K, Shiri R, Shiue I, Singh GM, Singh JA, Skirbekk V, Stapelberg NJ, Sturua L, Sykes BL, Tobias M, Tran BX, Trasande L, Toyoshima H, van de Vijver S, Vasankari TJ, Veerman JL, Velasquez-Melendez G, Vlassov VV, Vollset SE, Vos T, Wang C, Wang X, Weiderpass E, Werdecker A, Wright JL, Yang YC, Yatsuya H, Yoon J, Yoon SJ, Zhao Y, Zhou M, Zhu S, Lopez AD, Murray CJ, Gakidou E. Global, regional, and national prevalence of overweight and obesity in children and adults during 1980-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014 Aug 30;384(9945):766-81. doi: 10.1016/S0140-6736(14)60460-8. Epub 2014 May 29.
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Kral J, Machytka E, Horka V, Selucka J, Dolecek F, Spicak J, Kovarova V, Haluzik M, Buzga M. Endoscopic Treatment of Obesity and Nutritional Aspects of Bariatric Endoscopy. Nutrients. 2021 Nov 26;13(12):4268. doi: 10.3390/nu13124268.
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Glass J, Chaudhry A, Zeeshan MS, Ramzan Z. New Era: Endoscopic treatment options in obesity-a paradigm shift. World J Gastroenterol. 2019 Aug 28;25(32):4567-4579. doi: 10.3748/wjg.v25.i32.4567.
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Kim SH, Chun HJ. Endoscopic Treatment for Obesity: New Emerging Technology Trends. Gut Liver. 2015 Jul;9(4):431-2. doi: 10.5009/gnl15125. No abstract available.
Reference Type
BACKGROUND
Other Identifiers
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1005
Identifier Type: -
Identifier Source: org_study_id
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