NCT03638843

Brief Summary

Rapid metabolic improvements seen with sleeve gastrectomy are likely a result of changes in gastric origin. The gastric mucosa is an endocrine organ that regulates satiation pathways and is a complex regulator of food intake as well as lipid and glucose metabolism. This study aims to assess the efficacy and safety of endoscopic selective gastric mucosal devitalization (GMD) for the management of obesity and its related comorbidities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
2.1 years until next milestone

Study Start

First participant enrolled

September 25, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2021

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

10 months

First QC Date

August 16, 2018

Last Update Submit

July 19, 2021

Conditions

ObesityObesity, MorbidObesity; EndocrineBariatric Surgery Candidate

Keywords

bariatric endoscopyobesitymetabolic syndromegastric mucosal devitalizationEndoscopic bariatric therapies

Outcome Measures

Primary Outcomes (1)

  • Pathological changes

    Histopathological assessment to determine whether selective devitalization of mucosa and submucosa corresponds with decolorization during the in-vivo procedure.

    6 months

Secondary Outcomes (2)

  • Technical feasibility

    6 months

  • Procedural tolerability

    6 months

Study Arms (1)

Gastric mucosal devitalization arm

EXPERIMENTAL

Patients will be enrolled in the study after being scheduled to undergo vertical sleeve gastrectomy as part of routine clinical care, and the gastric mucosal devitalization procedure will be performed in-vivo utilizing Argon plasma coagulation three days before the operation.

Procedure: Gastric mucosal devitalization

Interventions

Gastric mucosal devitalizationPROCEDURE

Gastric mucosal devitalization is an endoscopic procedure which uses argon plasma coagulation to result in selective damage to the gastric mucosa and submucosa.

Gastric mucosal devitalization arm

Eligibility Criteria

Age28 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients scheduled to undergo vertical sleeve gastrectomy

You may not qualify if:

  • Age under 28 or older than 60
  • Insulin dependent Diabetes Mellitus
  • Suspected or biopsy confirmed liver cirrhosis
  • Significant ethanol consumption \>21 drinks/week in men and \>14 drinks/week in women
  • Presence of other chronic liver disease including hepatitis B-C, autoimmune hepatitis, alpha 1 antitrypsin deficiency, Wilson's disease, and hemochromatosis
  • Pregnant or breast-feeding
  • Patients who already have an intragastric balloon or other gastric implant
  • Patients with gastroesophageal reflux disease
  • Patients with previous gastric surgeries, altered gastrointestinal anatomy such as Billroth I, Billroth II, roux-en-y gastrectomy, roux-en-y hepaticojejunostomy, or any restrictive or bypass bariatric surgery
  • Patients with previous gastric embolization for obesity
  • Presence of inflammatory disorder of the gastrointestinal tract
  • Patients with active peptic ulcer disease
  • Patients with gastroesophageal varices
  • Presence of a large hiatal hernia (grade IV on Hills classification: large hiatal hernia and essentially no fold approximating the endoscope in the retroflexed view and where the lumen of the esophagus is gaping open allowing the squamous epithelium to be seen)
  • Structural abnormality in the esophagus or pharynx
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

ObesityObesity, MorbidMetabolic Syndrome

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Dilhana Badurdeen, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2018

First Posted

August 20, 2018

Study Start

September 25, 2020

Primary Completion

July 8, 2021

Study Completion

July 8, 2021

Last Updated

July 20, 2021

Record last verified: 2021-07

Locations

US(1)