Nonsurgical Reversible Obesity Treatment (NROT1)

NCT05420506 | Unknown

• 1 other identifier: 1005
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Morbid Obesity

Keywords

obesity treatment; non-surgical; small intestine; reversible

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (1)

NROT1

EXPERIMENTAL

Intestinal device placement in subjects and their follow up

Device: NROT1

Interventions

NROT1 DEVICE

Dental anchored intestinal placement of obesity treatment device with endoscopic intervention

NROT1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of morbid obesity
• Age limits: 18-65 years
• No history of gastrointestinal surgery
• Agreement for voluntary participation in the study

You may not qualify if:

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

Sponsors & Collaborators

• Yeditepe University: lead

Related Publications (28)

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MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Erhan Aysan, M.D.

  Yeditepe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erhan Aysan, M.D.

CONTACT

+90 2165780000; erhanaysan@hotmail.com

Umit A Keskin, Ph.D

CONTACT

+90 2165780000; auk@yeditepe.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 15, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share