NCT04207996

Brief Summary

This study aims to characterize how vagus nerve compound action potentials (CNAPs) conduct along the vagus nerve in gastroparetic patients receiving GES therapy using a flexible, non-invasive multielectrode array (MEA).

Trial Health

75
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress97%
Sep 2019Aug 2026

Study Start

First participant enrolled

September 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 23, 2019

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

7 years

First QC Date

December 17, 2019

Last Update Submit

March 4, 2026

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (2)

  • Optimal MEA configuration

    Identify the optimal MEA configuration for vagal response capture

    3 years

  • GES and symptom survey

    Identify the compound nerve action potential in each subject and correlate that with the symptom survey data collected for each subject

    3 years

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All subjects 18 years and above who have a gastric electrical stimulator placed for gastroparesis

You may qualify if:

  • Gastroparetic patient with a stimulator (Enterra Device placed)
  • Aged 18-80 years
  • Willing to have electrodes placed on the neck

You may not qualify if:

  • Unable to provide consent
  • Pregnant females
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Hosptial

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas V Nowak, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor and Principal Investigator

Study Record Dates

First Submitted

December 17, 2019

First Posted

December 23, 2019

Study Start

September 1, 2019

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)