NCT02905669

Brief Summary

Impedance planimetry using Endoscopic Functional Lumen Imaging Probe (EndoFLIP) device is a promising diagnostic tool to assess esophageal, esophago-gastric junction and pylorus function. It allows the measurement of esophageal and pylorus distensibility as well as contractile activity in response to distension. Examination is useful performed under sedation. General anesthesia might affect distensibility values. The aim of this study is to normal values for esophageal, esophago-gastric junction and pylorus distensibility in controls during an upper gastro-intestinal endoscopy performed under general anesthesia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

September 13, 2017

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2024

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

6.7 years

First QC Date

September 9, 2016

Last Update Submit

March 18, 2022

Conditions

Esophageal DysfunctionPylorus Dysfunction

Keywords

distensibilityimpedance planimetryesophagusesophago-gastric junctionpylorus

Outcome Measures

Primary Outcomes (1)

  • Esophago-gastric junction distensibility

    The day of gastro-intestinal endoscopy

Secondary Outcomes (5)

  • Esophageal distensibility

    The day of gastro-intestinal endoscopy

  • Pylorus distensibility

    The day of gastro-intestinal endoscopy

  • Esophageal contractile activity in response to distension

    The day of gastro-intestinal endoscopy

  • Side effects occurence

    The day of gastro-intestinal endoscopy

  • Side effects occurence

    The day after gastro-intestinal endoscopy

Study Arms (1)

EndoFLIP

EXPERIMENTAL

Esophago-gastric junction distensibility will be assessed in patients thanks to impedance planimetry using EndoFLIP device.

Device: EndoFLIP

Interventions

EndoFLIPDEVICE

Esophago-gastric junction distensibility will be assessed in patients thanks to impedance planimetry using EndoFLIP device

EndoFLIP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject older than 18 years and younger than 80 years
  • Subject referred for upper gastro-intestinal endoscopy under general anesthesia for anemia, intestinal metaplasia in the stomach, Helicobacter pylori screening, or submucosal dissection
  • Subject with health insurance
  • Written informed consent

You may not qualify if:

  • Patient younger than 18 years or older than 80 years
  • Pregnancy or breast feeding
  • Previous history of esophago-gastric surgery or vagotomy
  • Previous history of Parkinson disease or diabetes mellitus
  • Contra-indication to upper gastro-intestinal endoscopy
  • Esophageal varices
  • Esophageal diameter smaller than 5 mm
  • Contra-indication to general anesthesia
  • Hiatal hernia greater than 3 cm on endoscopy
  • Esophageal or gastric cancer otherwise than superficial lesion with indication of submucosal dissection
  • Typical symptoms (heartburn, regurgitation) of gastro-esophageal reflux disease and/or gastroesophageal reflux disease (GERD)-Q score greater or equal to 8
  • Nausea, vomiting or epigastric pain
  • Dysphagia with Sydney score greater ou equal to 50
  • Incapability to give consent
  • No written informed consent
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exploration Fonctionnelle Digestive, Hôpital Edouard Herriot

Lyon, 69437, France

RECRUITING

MeSH Terms

Conditions

Esophageal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Sabine ROMAN, MD, PhD

CONTACT

+33472110146sabine.roman@chu-lyon.fr

Study Design

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

Study Record Dates

First Submitted

September 9, 2016

First Posted

September 19, 2016

Study Start

September 13, 2017

Primary Completion

May 25, 2024

Study Completion

May 25, 2024

Last Updated

March 21, 2022

Record last verified: 2022-03

Locations

FR(1)