Use of EndoFLIP and Manometry Prior to G-POEM

NCT04844190 | Withdrawn FDA Device

• 1 other identifier: STU00213007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Gastroparesis

Keywords

G-POEM; High Resolution Manometry; Endoscopic Functional Lumen Imaging Probe

Outcome Measures

Primary Outcomes (2)

• Predictive Value of EndoFLIP

  To assess the predictive value of EndoFLIP for clinical response to G-POEM in patients with refractory gastroparesis. We hypothesize that patients with lower pyloric distensibility (measured in mm2/mmHg) will be predictive of clinical response to G-POEM.

  24 months

• Predictive Value of ADM

  To assess the predictive value of high resolution ADM for clinical response to G-POEM in patients with refractory gastroparesis. We hypothesize that patients with a large, positive pressure gradient will be predictive of clinical response to G-POEM.

  24 months

Secondary Outcomes (5)

• EndoFLIP data correlation

  24 months

• Quality of Life outcome of G-POEM

  36 months

• Quality of Life outcome assessed by SF-36 QOL survey questionnaire

  36 months

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  36 months

• Gastric-Emptying Characteristics

  36 months

Study Arms (1)

Addition of ADM and EndoFLIP to pre-G-POEM evaluation

EXPERIMENTAL

During the preoperative upper endoscopy, the EndoFLIP catheter is inserted through the mouth with endoscopic guidance and placed through the gastric pylorus. Once deployed, water is sequentially added at set volumes to a balloon that can be used to measure pyloric diameter, cross-sectional area, pressure, and distensibility at set volumes of 30, 40, and 50 mL for at least five seconds. We will record this data for each patient. The EndoFLIP catheter will then be removed. Subsequently, a high resolution ADM catheter will be inserted through the nose and placed through the pylorus to measure baseline intragastric, transpyloric, and intraduodenal pressures. The patient will be observed for up to four hours to assess a migrating motor complex (MMC). After the MMC is observed, the patient will be given a meal and observed for meal response with the manometry catheter. The meal will be water and two pieces of toast/bread. Following the meal, the catheter will be removed.

Diagnostic Test: EndoFLIP; Diagnostic Test: Antroduodenal Manometry

Interventions

EndoFLIP DIAGNOSTIC_TEST

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).

Addition of ADM and EndoFLIP to pre-G-POEM evaluation

Antroduodenal Manometry DIAGNOSTIC_TEST

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.

Addition of ADM and EndoFLIP to pre-G-POEM evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients aged 18+ diagnosed with refractory gastroparesis as defined earlier in this document, no age limit
• Patients already consented to undergo G-POEM

You may not qualify if:

• Patients who are pregnant(at Northwestern, all female patients have urine pregnancy tests on day of endoscopy), vulnerable populations such as prisoners,
• Life expectancy \< 1 year based on concurrent comorbidities based on study team assessment,
• Coagulopathy with INR \> 1.5 that cannot be reversed,
• Thrombocytopenia with platelets \< 50,000 that cannot be corrected with blood products,
• Unable to safely undergo elective endoscopy due to current comorbidities, and inability to pass standard endoscope.
• Patients with history of gastric surgery and

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (15)

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  PMID: 24120337 RESULT

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  PMID: 31809720 RESULT

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  PMID: 30653937 RESULT

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective Study

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: April 14, 2021
• Study Start: September 15, 2021
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)