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Predicting Outcomes of GPOEM Using Gastric Electrical Mapping - Trial NCT06381349

Access comprehensive clinical trial information for NCT06381349 through Pure Global AI's free database. This phase not specified trial is sponsored by Chris Varghese and is currently Not yet recruiting. The study focuses on Gastroparesis. Target enrollment is 300 participants.

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NCT06381349
Not yet recruiting
diagnostic test
Trial Details
ClinicalTrials.gov โ€ข NCT06381349
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Predicting Outcomes of GPOEM Using Gastric Electrical Mapping
Predicting Outcomes of Gastric Peroral Endoscopic Myotomy Using a Gastric Electrical Mapping System: GPOEM-GEMS

Study Focus

Gastroparesis

Gastric Alimetry test

Observational

diagnostic test

Sponsor & Location

Chris Varghese

University of Auckland, New Zealand

Timeline & Enrollment

N/A

May 01, 2024

Jun 01, 2026

300 participants

Primary Outcome

Gastroparesis Cardinal Symptom Index (GCSI)

Summary

Gastric peroral endoscopic myotomy (GPOEM) is a minimally-invasive procedure that involves
 dividing the pylorus, to enhance gastric emptying in gastroparesis patients. This is a
 single-arm, multi-centre, prospective observational study to determine the clinical utility
 of Gastric Alimetry in predicting GPOEM treatment outcomes. The investigators further aim to
 develop a clinical decision rule to inform patient selection. Gastric Alimetry will be
 conducted 1 month prior to GPOEM. All subjects will then be followed up for 12 months.

ICD-10 Classifications

Attention to gastrostomy
Gastrostomy status
Other gastritis
Gastritis, unspecified
Gastric diverticulum

Data Source

ClinicalTrials.gov

NCT06381349

Non-Device Trial