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Use of EndoFLIP and Manometry Prior to G-POEM

NCT04844190 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-09-22

No results posted yet for this study

Summary

The purpose of this study is to assess physiologic response of therapy in patients with refractory gastroparesis undergoing Gastric per-oral endoscopic myotomy (G-POEM) using endoscopic functional lumen imaging probe (EndoFLIP) and antroduodenal manometry (ADM). Refractory gastroparesis will be defined as having delayed gastric emptying at four hours (\>10% retention of stomach contents) on gastric scintigraphy and persistent symptoms despite treatment with dietary modification or prokinetic medications. We hypothesize that EndoFLIP and high resolution ADM will provide an individualized pyloric functional profile in gastroparesis patients that can more accurately predict clinical response to G-POEM.

Conditions

Interventions

DIAGNOSTIC_TEST

EndoFLIP

During pre-G-POEM upper endoscopy, an EndoLIP catheter will be inserted through the patient's mouth into the stomach and across the pylorus. Once results of EndoFLIP are obtained, the catheter will be removed (5 minutes).

DIAGNOSTIC_TEST

Antroduodenal Manometry

Following removal the EndoFLIP catheter, a manometry catheter will then be placed through the nose and advanced across the pylorus. Once catheter positioning is confirmed on endoscopy, the endoscope will be withdrawn. The manometry catheter will be taped to the nose and sedation stopped. The patient will be brought to the recovery area where they will wake-up with the catheter in place. In a private recovery room, the patient will have the catheter in place (no positioning or movement restrictions). When pyloric spasms are documented (0.5-4 hours), they will be given a standard small meal (water, toast/bread). Once motility is assessed with eating, the manometry catheter will be removed.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2024-03-01
Completion
2024-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04844190 on ClinicalTrials.gov