NCT03270722

Brief Summary

FLIP topography has been FDA cleared to evaluate a variety of esophageal conditions, but has never been evaluated in patients with scleroderma. The investigators hope to evaluate this technology in patients who have scleroderma and various esophageal symptoms, and compare to non-scleroderma patients.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

August 18, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

2.3 years

First QC Date

August 18, 2017

Last Update Submit

January 16, 2021

Conditions

SclerodermaDysphagiaGERD - Gastro-Esophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

  • FLIP topography pattern

    This is the readout or topographic map that is generated from the FLIP topography diagnostic procedure. We will look to see if we can make additional diagnoses not made by other clinical testing, to see if the diagnoses made by FLIP topography match with other diagnostic testing, and identify new FLIP topography patterns in patients with scleroderma not seen before.

    Will be analyzed directly after the procedure for an individual patient within 2 weeks. Comparisons within and between the 3 groups will be done at the conclusion of the study (once 60 total patients have been recruited).

Secondary Outcomes (1)

  • Change in medical management

    Recommendations will be made directly after the procedure. Chart reviews at 6 months will also occur to monitor implementation of medical recommendations.

Study Arms (3)

patients with scleroderma and trouble swallowing

EXPERIMENTAL
Device: FLIP topographyProcedure: Upper Endoscopy

patients with scleroderma but no trouble swallowing

EXPERIMENTAL
Device: FLIP topographyProcedure: Upper Endoscopy

patients without scleroderma undergoing endoscopy

ACTIVE COMPARATOR
Device: FLIP topographyProcedure: Upper Endoscopy

Interventions

FLIP topographyDEVICE

During upper endoscopy, the FLIP topography balloon will be advanced into the esophagus and inflated, providing additional information about the distensibility of the esophagus. This generally takes about 5 extra minutes and no complications have been reported. Theoretical complications include bleeding, infection, risk with extra anesthesia time, and putting a hole in the esophagus.

patients with scleroderma and trouble swallowingpatients with scleroderma but no trouble swallowingpatients without scleroderma undergoing endoscopy
Upper EndoscopyPROCEDURE

A standard upper endoscopy will also be done in all patients. A small scope will be passed via the mouth to examine the esophagus, stomach, and first part of the small intestine. The risks of this procedure include the risks associated with anesthesia, a small risk of bleeding, infection, and a very small risk of putting a hole in the gastrointestinal tract.

Also known as: EGD (esophagogastroduodenoscopy)
patients with scleroderma and trouble swallowingpatients with scleroderma but no trouble swallowingpatients without scleroderma undergoing endoscopy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must have a clinical indication for upper endoscopy (recruiting patients both with scleroderma and without)

You may not qualify if:

  • not healthy enough to undergo an upper endoscopy
  • mass, stricture, ring, or web present on upper endoscopy
  • history of esophageal cancer
  • history of esophageal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Healthcare

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Scleroderma, DiffuseDeglutition DisordersGastroesophageal Reflux

Interventions

GastroscopyEndoscopy, Digestive System

Condition Hierarchy (Ancestors)

Scleroderma, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesEsophageal Motility Disorders

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow in Gastroenterology

Study Record Dates

First Submitted

August 18, 2017

First Posted

September 1, 2017

Study Start

January 1, 2018

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

January 20, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)