G-POEM for Treatment of Refractory Gastroparesis
Observational Study of the Efficacy and Outcomes of Gastric Peroral Endoscopic Myotomy (G-POEM) for Treatment of Refractory Gastroparesis
1 other identifier
observational
80
1 country
1
Brief Summary
This study is performed to assess the efficacy and outcomes of Gastric Per Oral Endoscopic Myotomy "G-POEM" in patients presenting with gastroparesis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2015
Longer than P75 for all trials
1 active site
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
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 30, 2016
CompletedFirst Posted
Study publicly available on registry
April 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedAugust 21, 2020
August 1, 2020
4.9 years
March 30, 2016
August 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy of the G-POEM
Improvement in patients symptoms as evaluated by the Gastroparesis Cardinal Symptom Index (GCSI) at 1 month, 3 months, 6 months and 1 year. The GCSI consists of three sub-scales: nausea/vomiting (three items), post-prandial fullness/early satiety (four items) and bloating (two items). Each item is rated on a Likert scale ranging from 0 (none) to 5 (very severe). Subscales are the average of different sets of items and are reported as a number between 0 to 5. Efficacy will be defined as a decrease in the GCSI score average below 2.
Up to 1 year
Secondary Outcomes (4)
Patient symptom improvement
Up to 1 year
Delayed gastric emptying using a Gastric emptying study
3 months
Imapct of the G-POEM on patients' Quality of life
Up to 1 year
Efficacy of the G-POEM
1 year
Study Arms (1)
Gastric Per Oral Endoscopic Myotomy
All patients presenting with Gastroparesis will undergo Per oral endoscopic gastric myotomy
Interventions
Patients will receive Per Oral Endoscopic Gastric Myotomy for Gastroparesis.
Eligibility Criteria
Individuals who initially approach the study team from outside the institution (e.g. responding to the clinicaltrials.gov listing) or patients seen in the gastroenterology clinic.
You may qualify if:
- Adult patient age greater than 18 years old who are undergoing a standard-of-care G-POEM procedure.
You may not qualify if:
- Previous surgery of the esophagus or stomach which has resulted in a resection of the antrum and pylorus
- Known active gastroesophageal malignancy
- Prior surgical or laparoscopic pyloromyotomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Related Publications (1)
Vosoughi K, Ichkhanian Y, Benias P, Miller L, Aadam AA, Triggs JR, Law R, Hasler W, Bowers N, Chaves D, Ponte-Neto AM, Draganov P, Yang D, El Halabi M, Sanaei O, Brewer Gutierrez OI, Bulat RS, Pandolfino J, Khashab M. Gastric per-oral endoscopic myotomy (G-POEM) for refractory gastroparesis: results from an international prospective trial. Gut. 2022 Jan;71(1):25-33. doi: 10.1136/gutjnl-2020-322756. Epub 2021 Mar 19.
PMID: 33741641DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mouen A Khashab, MD
Johns Hopkins University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2016
First Posted
April 11, 2016
Study Start
May 1, 2015
Primary Completion
April 1, 2020
Study Completion
April 1, 2020
Last Updated
August 21, 2020
Record last verified: 2020-08