Clinical trial NCT04006002: Mechanism of Weight Loss After Endoscopic and Laparoscopic Sleeve Procedures
Official title: A Pilot Study to Compare Anatomic, Physiologic, Metabolic and Weight Changes After Standard of Care Endoscopic Gastric Restrictive Bariatric Interventions vs. Standard of Care Laparoscopic Sleeve Gastrectomy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Weight Loss
Reflux
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only participants who meet all eligibility criteria will be enrolled in the study. Participants who meet all eligibility criteria and have successfully completed the screening requirements will be asked to sign a Study Consent.

Patients undergoing endoscopic or laparoscopic weight loss procedures will be included.

Brief summary: The purpose of this research study is to understand the mechanism of weight loss for weight loss procedures: that is Laparoscopic sleeve gastrectomy and Endoscopic sleeve Gastroplasty.

Detailed description: We want to better understand the mechanisms for weight loss by understanding the anatomic and physiologic changes that occur with gastric restrictive procedures for weight loss and to determine the differences in metabolic profile between the two restrictive procedures. We also want to identify the rate of Gastro Esophageal Reflux Disease (GERD) in patients undergoing gastric restrictive procedures for weight loss.

Eligibility criteria: Inclusion Criteria:

1. BMI ≥ 30 Kg/m2 scheduled to undergo a bariatric intervention
2. Patients who will be undergoing ESG or LSG as part of their clinical care Age between 18 and 75 years.
3. Both male and female subjects will be included in the study.
4. Subjects from any ethnic background will be included in the study.
5. Female participants of childbearing age should not be pregnant. (Pregnancy test will be performed on all women of child bearing potential before any standard of care endoscopic procedure. For the purpose of the study we will record that information in the patient study records).
6. Successfully complete the screening process.
7. Patients able to provide written informed consent on the IRB/EC-approved informed consent form.
8. Demonstrate willingness to follow protocol requirements, including follow-up schedule, and completion of questionnaires.
9. Having standard of care therapy (endoscopic or laproscopic) for treatment of Obesity.

Exclusion Criteria:

1. Pregnant or planning to become pregnant during period of study participation.
2. Female participants who are breast-feeding.
3. Severe Immunodeficiency.
4. Severe malnutrition.
5. The participant has life expectancy of less than 1 year due to other medical conditions.

Primary outcomes:
measure: Percentage of participants with GERD before and after intervention
timeFrame: 1 years
Secondary outcomes:
measure: Compare gastric emptying after intervention
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Northwell Health
state: New York
Study officials:
affiliation: Northwell Health
name: Petros Benias, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jirapinyo P, Thompson CC. Endoscopic Bariatric and Metabolic Therapies: Surgical Analogues and Mechanisms of Action. Clin Gastroenterol Hepatol. 2017 May;15(5):619-630. doi: 10.1016/j.cgh.2016.10.021. Epub 2016 Oct 28.
citation: Novikov AA, Afaneh C, Saumoy M, Parra V, Shukla A, Dakin GF, Pomp A, Dawod E, Shah S, Aronne LJ, Sharaiha RZ. Endoscopic Sleeve Gastroplasty, Laparoscopic Sleeve Gastrectomy, and Laparoscopic Band for Weight Loss: How Do They Compare? J Gastrointest Surg. 2018 Feb;22(2):267-273. doi: 10.1007/s11605-017-3615-7. Epub 2017 Nov 6.
citation: Fogel R, De Fogel J, Bonilla Y, De La Fuente R. Clinical experience of transoral suturing for an endoluminal vertical gastroplasty: 1-year follow-up in 64 patients. Gastrointest Endosc. 2008 Jul;68(1):51-8. doi: 10.1016/j.gie.2007.10.061. Epub 2008 Mar 19.