NCT05507151

Brief Summary

Endoscopic weight loss procedures, also termed endoscopic sleeve gastroplasty (ESG), has been proposed as a non-surgical procedure for managing obesity and offers a standard weight loss approach. Realizing there is a knowledge gap in applying ESG to morbidly obese patients with NAFLD, the investigators propose studying the efficacy of weight control and functional outcomes of ESG. This prospective pilot study is aimed to study the safety profiles, quality of life, and changes and improvements in the anthropometric, metabolic, and biochemical changes in these patients.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

August 24, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

3.7 years

First QC Date

August 16, 2022

Last Update Submit

April 23, 2026

Conditions

Nonalcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (6)

  • Change in Controlled Attenuation Parameter of Steatosis

    The CAP measures ultrasonic attenuation in the liver at 3.5 MHz using signals acquired by the FibroScan® M probe based on vibration-controlled transient elastography. The final CAP value, which ranges from 100 to 400 decibels per metre (dB/m), is the median of individual measurements. Higher measure indicates higher portion of liver affected by fatty change.

    Baseline (Before ESG)

  • Change in Controlled Attenuation Parameter of Steatosis

    The CAP measures ultrasonic attenuation in the liver at 3.5 MHz using signals acquired by the FibroScan® M probe based on vibration-controlled transient elastography. The final CAP value, which ranges from 100 to 400 decibels per metre (dB/m), is the median of individual measurements. Higher measure indicates higher portion of liver affected by fatty change.

    6 months post ESG

  • Change in Controlled Attenuation Parameter of Steatosis

    The CAP measures ultrasonic attenuation in the liver at 3.5 MHz using signals acquired by the FibroScan® M probe based on vibration-controlled transient elastography. The final CAP value, which ranges from 100 to 400 decibels per metre (dB/m), is the median of individual measurements. Higher measure indicates higher portion of liver affected by fatty change.

    12 months post ESG

  • Change in Liver Stiffness Measurement of Fibrosis

    Liver stiffness result is measured in kilopascals (kPa) Range is 0-75kPa. Normal results are usually between 2 and 7 kPa. The highest possible result is 75 kPa. Higher results indicate liver disease.

    Baseline (Before ESG)

  • Change in Liver Stiffness Measurement of Fibrosis

    Liver stiffness result is measured in kilopascals (kPa) Range is 0-75kPa. Normal results are usually between 2 and 7 kPa. The highest possible result is 75 kPa. Higher results indicate liver disease.

    6 months post ESG

  • Change in Liver Stiffness Measurement of Fibrosis

    Liver stiffness result is measured in kilopascals (kPa) Range is 0-75kPa. Normal results are usually between 2 and 7 kPa. The highest possible result is 75 kPa. Higher results indicate liver disease.

    12 months post ESG

Secondary Outcomes (9)

  • Anthropometric Evaluation

    6 months post ESG

  • BMI Changes

    6 months post ESG

  • BMI Changes

    12 months post ESG

  • Excess Weight Loss Changes

    6 months post ESG

  • Excess Weight Loss Changes

    12 months post ESG

  • +4 more secondary outcomes

Study Arms (1)

Endoscopic Sleeve Gastroplasty

endoscopic suturing of the stomach

Procedure: Endoscopic Sleeve Gastroplasty

Interventions

Endoscopic Sleeve GastroplastyPROCEDURE

endoscopic suturing of the stomach

Endoscopic Sleeve Gastroplasty

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

30 obese patients undergoing an endoscopic sleeve gastroplasty (ESG).

You may qualify if:

  • Body mass index (BMI) greater than 30 kg/m2, who are eligible for ESG
  • Patients scheduled to undergo an endoscopic bariatric weight loss procedure (ESG)
  • Patients older than 18 years and younger than 75 years of age at the time of consent
  • Patients able to provide written informed consent on the Institutional review board (IRB) approved informed consent form
  • Patients willing and able to comply with study requirements for follow-up

You may not qualify if:

  • Patients who are treated with intragastric balloons
  • Family history of esophageal, gastric, or duodenal malignancy and active gastric ulceration,
  • Pre-existing esophageal stenosis/stricture preventing the advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
  • Presence of any gastric condition which required endoscopic surveillance (e.g., known gastric intestinal metaplasia),
  • Known vascular abnormalities, obligate therapeutic anticoagulation, and pregnancy/lactation
  • Evidence of end-stage liver disease, including portal hypertension, ascites, and coagulopathy
  • Positivity for hepatitis B virus or hepatitis C virus, current alcohol consumption of more than 20 g/day in females and more than 30 g/day in males on average, use of medications with reported hepato-steatogenic effect (amiodarone, tamoxifen, estrogens), and drug-induced liver disease
  • Type 1 diabetes, Prior bariatric surgery, Autoimmune liver disease (antinuclear antibody titer \>1/160), Wilson's disease, hemochromatosis, alpha1-antitrypsin deficiency,
  • Known positivity for human immunodeficiency virus, a concomitant disease with reduced life expectancy, severe psychiatric condition, drug dependence, or inability to provide informed consent.
  • The patient refuses or is unable to provide written informed consent
  • Prior bariatric treatment procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26508, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Shailendra Singh, MD

    West Virginia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 18, 2022

Study Start

August 24, 2022

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations

US(1)