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NCT Number: NCT04434781

Gastric Per-Oral Endoscopic Myotomy (G-POEM) for the Treatment of Gastroparesis

Gastric Per-Oral Endoscopic Myotomy (G-POEM) is a procedure for the Treatment of Gastroparesis.

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Key information

Conditions

Gastroparesis Digestive System Diseases Gastrointestinal Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location status: Recruiting

Location contact

Mohammad Al-Haddad, MD

CONTACT

[email protected]

3179440980

About this study

Gastroparesis is a disease of the stomach where there is significant delay in gastric emptying of contents to the intestines. This disease results in a multitude of symptoms including nausea, vomiting, weight loss, and malnutrition.

Current treatments for gastroparesis include dietary changes, oral medications (prokinetic agents to enhance gastric motility, acid reducers, anti-emetics to reduce nausea and vomiting), gastric stimulators and rarely surgery.

G-POEM (Gastric Per-Oral Endoscopic Myotomy-creating a cut in the muscle that controls gastric emptying), an incision-less (no cutting of the surface of the body) endoscopic procedure, is increasingly being performed to assist in the management of certain groups of patients with gastroparesis.

This data will be used for research purposes only to determine the clinical impact of endoscopic treatments on gastroparesis. The physicians will also be able to better understand the patient's condition and disease process that may lead to improved standard of care and improved patient management.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age
  • Referral for endoscopic treatment of Gastroparesis for symptom management

Exclusion criteria

  • < 18 years of age
  • Absence of gastroparesis based on scintigraphy studies

Treatment and study plan

Primary outcomes

  1. Assessment of Change in Gastroparesis Cardinal Symptom Index (GCSI) from baseline to post G-POEM

    Time frame: 60 months span: baseline and assess change at 1 month, 3 month, 6 month, 12 month, 24 month, 36 month, 48 month & 60 months

    The Gastroparesis Cardinal Symptom Index (GCSI) is used for assessing severity of symptoms associated with gastroparesis. Patients are to score each of the 9 symptom criteria on 0 (None) to 5 (Very Severe) Likert Scale. The higher the score the more symptomatic from gastroparesis the patient is.

    Nausea or Vomiting (score 0-5 for each of the following 3 criteria)

    • Nausea
    • Retching
    • Vomiting Postprandial fullness or early satiety (score 0-5 for each of the following 4 criteria)
    • Stomach Fullness
    • Not able to finish a normal-sized meal
    • Feeling excessively full after meals
    • Loss of appetite Bloating (score 0-5 for each of the following 2 criteria)
    • Bloating
    • Stomach visibly larger

  2. Assessment of Change in Patient Assessment of gastrointestinal disorders-symptom severity index (PAGI-SYM) score from baseline to post G-POEM

    Time frame: 60 months span: baseline and assess change at 1,3,6,12,24, 36,48 & 60 months

    Change in PAGI-Sym score: The PAGI-SYM is composed of 20 items and 6 subscales: heartburn/regurgitation (7 items), nausea/vomiting (3 items), postprandial fullness/early satiety (4 items), bloating (2 items), upper abdominal pain (2 items), and lower abdominal pain (2 items). Subscale scores are calculated by averaging across items comprising the subscale; scores vary from 0 (none or absent) to 5 (very severe)

  3. Assessment of Change in G-POEM SF-36 Health Survey score from baseline to post G-POEM

    Time frame: baseline and assess change at 1,3,6,12,24,36,48 & 60 months

    Change in health belief questionnaire (SF-36) score: Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability and the higher scores indicate better health

  4. Assessment of change in Gastric Emptying Scan (GES) (solid phase, 4 hour study) from baseline to post G-POEM

    Time frame: baseline; and assess change at 6, and 24 months

    we will track change in GES at 6 months and 24 months post G-POEM and compare to baseline. Normal GES should have under 5% at 4 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Jacque Peterman

CONTACT

[email protected]

317-944-0980

Mohammad Al-Haddad, MD

CONTACT

[email protected]

317-944-0980

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Gastric Per-Oral Endoscopic Myotomy (G-POEM) for the Treatment of Gastroparesis: A Database Repository

Acronym: G-POEM

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2020
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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