Gastric Mapping for Gastroparesis

Recruiting in Palo Alto (17 mi)

Overseen by Mohammad Al-Haddad, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Indiana University

Disqualifiers: Pregnant, Breast-feeding, Spinal injuries, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to investigate whether or not the investigators can utilize Body Surface Gastric Mapping to determine who would best benefit to receive G-POEM procedure and how Body Surface Gastric Mapping can be utilized with patients who have gastroparesis symptoms. the investigators may also be able to find more ways how Body Surface Gastric Mapping testing can benefit patients with gastroparesis and/or G-POEM procedure.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Gastric Mapping for Gastroparesis is an effective treatment?

The available research shows that Gastric Mapping for Gastroparesis, also known as G-POEM, is considered a promising treatment for people with severe and hard-to-treat gastroparesis. Several studies highlight its potential benefits. For instance, a systematic review and meta-analysis found it to be effective and safe for treating this condition. Additionally, a pilot trial described it as a minimally invasive option with positive results. Although still experimental, these studies suggest that G-POEM could be a valuable alternative for those who do not respond well to other treatments.

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What safety data is available for G-POEM treatment?

Several studies have evaluated the safety of Gastric Peroral Endoscopic Myotomy (G-POEM) for treating refractory gastroparesis. An international multicenter study comprehensively analyzed adverse events associated with G-POEM, identifying predictive factors for these events. Additionally, a systematic review and meta-analysis assessed the safety and efficacy of G-POEM, comparing it to surgical pyloroplasty. These studies indicate that G-POEM is a promising and minimally invasive treatment option, though data on safety and efficacy are still being gathered.

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Is G-POEM a promising treatment for gastroparesis?

Yes, G-POEM is a promising treatment for gastroparesis. It is a new, minimally invasive technique that has shown potential in helping patients with this condition. Studies suggest it could be an effective option for those who haven't responded well to other treatments.

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Eligibility Criteria

This trial is for individuals with gastroparesis, a condition where the stomach empties too slowly. Participants should be candidates for or have had a G-POEM procedure. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I am considered a candidate for the G-Poem procedure at this hospital.

Exclusion Criteria

Pregnant or breast-feeding

I have a drain or tube placed in my abdomen.

I have gastroparesis because of a spinal cord injury.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo Body Surface Gastric Mapping (BSGM) and other baseline assessments prior to G-POEM procedure

1 week

1 visit (in-person)

Treatment

Participants undergo the G-POEM procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in BSGM measures, symptoms, and quality of life at 3 and 6 months post-G-POEM

6 months

2 visits (in-person)

Participant Groups

The study is testing if Body Surface Gastric Mapping, a non-invasive test, can predict who will benefit from G-POEM (a procedure to help food leave the stomach faster) and monitor its success in patients with gastroparesis.

Group I: Body Surface Gastric Mapping Experimental Treatment 1 Intervention

G-POEM is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as G-POEM for:

• Gastroparesis

🇪🇺 Approved in European Union as G-POEM for:

• Gastroparesis

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Indiana University Health University Hospital Indianapolis, IN

Who Is Running the Clinical Trial?

Indiana University Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Gastric Peroral Endoscopic Myotomy: A Specific Learning Curve. [2023] Gastric peroral endoscopic pyloromyotomy (G-POEM) is a novel option for patients with gastroparesis. It involves submucosal tunneling across the pylorus, followed by pyloromyotomy, and subsequent closure of the endoscopic tunnel. The aim of this study was to determine the learning curve for G-POEM.

2. Spain pubmed.ncbi.nlm.nih.gov

Gastric per-oral endoscopic myotomy (G-POEM) is a promising treatment for refractory gastroparesis: a systematic review and meta-analysis. [2021] to evaluate the efficacy and safety of gastric per-oral endoscopic myotomy (G-POEM) for the treatment of refractory gastroparesis.

3. England pubmed.ncbi.nlm.nih.gov

Endoscopic pyloromyotomy for the treatment of severe and refractory gastroparesis: a pilot, randomised, sham-controlled trial. [2022] Endoscopic pyloromyotomy (G-POEM) is a minimally invasive treatment option with promising uncontrolled outcome results in patients with gastroparesis.

4. England pubmed.ncbi.nlm.nih.gov

G-POEM with antro-pyloromyotomy for the treatment of refractory gastroparesis: mid-term follow-up and factors predicting outcome. [2018] Gastric peroral endoscopic pyloromyotomy (G-POEM) was introduced for treating refractory gastroparesis.

5. Czech Republic pubmed.ncbi.nlm.nih.gov

Successful repeated gastric peroral endoscopic myotomy (re-G-POEM) in the treatment of postsurgical gastroparesis. [2022] Gastric peroral endoscopic myotomy (G-POEM) is a promising but still experimental endoscopic method for the treatment of gastroparesis.

6. Germany pubmed.ncbi.nlm.nih.gov

Gastric per-oral endoscopic myotomy for refractory gastroparesis: a detailed description of the procedure, our experience, and review of the literature. [2019] Gastric per-oral endoscopic myotomy (G-POEM) was introduced four years ago as an investigational procedure for refractory gastroparesis. The safety and efficacy were currently evaluated. With our recent studies on G-POEM, we share our experience and knowledge through the discussion of a detailed description of the procedure and review of the literature. To our knowledge, this is the first systemic review on this new therapeutic endoscopic procedure.

7. Germany pubmed.ncbi.nlm.nih.gov

Comprehensive Analysis of Adverse Events Associated with Gastric Peroral Endoscopic Myotomy: An International Multicenter Study. [2021] Gastric peroral endoscopic myotomy (G-POEM) has emerged as an effective management approach for patients with refractory gastroparesis. This study aims to comprehensively study the safety of G-POEM and describe the predictive factors of adverse events (AEs) occurrence.

8. Germany pubmed.ncbi.nlm.nih.gov

Clinical efficacy of gastric per-oral endoscopic myotomy (G-POEM) in the treatment of refractory gastroparesis and predictors of outcomes: a systematic review and meta-analysis using surgical pyloroplasty as a comparator group. [2021] Gastric peroral endoscopic myotomy (G-POEM) is a novel minimally invasive technique in endosurgery. Data is limited as to its efficacy, safety, and predictive factors. We conducted this meta-analysis to evaluate the clinical outcomes of G-POEM and used the outcomes of surgical pyloroplasty as a comparator group in the treatment of refractory gastroparesis.