Gastric Electrical Stimulation for Abdominal Pain in Gast... | NCT04121325

Studies
Gastric Electrical Stimulation for Abdominal Pain in Gastroparesis

NCT04121325

Sponsor

University of Louisville

Status

Terminated

Last Update Posted

Oct 27, 2023Actual

Enrollment

4Actual

Phase

Not provided

Conditions

Abdominal Pain

Interventions

Enterra

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

pandemic

Expanded Access Info

Start Date

Dec 18, 2019Actual

Primary Completion Date

Mar 13, 2020Actual

Completion Date

Mar 13, 2020Actual

First Submitted Date

Oct 4, 2019

First Submission Date that Met QC Criteria

Oct 8, 2019

First Posted Date

Oct 9, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2023

Last Update Posted Date

Oct 27, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To conduct a pilot study to evaluate the effects of new GES programming settings on abdominal pain in patients with gastroparesis and existing GES devices, whose abdominal pain has so far been refractory to drugs and/or devices.

Detailed Description

Eligible patients will undergo detailed pain assessments as well as non-invasive physiologic assessment. Patients existing GES devices will be reprogrammed to new setting for 4 week and their GI symptoms including pain will be evaluated by a daily diary. At the end of 4 weeks detailed pain assessments and noninvasive physiologic assessments will be repeated.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gastroparesis patients with abdominal pain		Patients with gastroparesis who have had an Enterra device in place for at least two months who continue to have moderate to severe abdominal pain.	Device: Enterra

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enterra	Device	To measure validated and subjective pain scores among patients with an existing GES device, and who have a trial of new settings directed at abdominal pain and compare their pain scores to each patient baseline symptoms, done with their previous GES settings.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Abdominal Pain	Abdominal Pain by Brief Pain Inventory. The values are 0-10, with 10 being worse outcome.	4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Should be able to give informed consent for the study
Has Enterra GES device in place for at least 2 months
Continue to have moderate to severe abdominal pain on at least one pain questionnaire or >5 score (on a scale of 0-10 for pain) on the VAS questionnaire for at least 2 months.
Abdominal pain should be either persistent; for example, daily for at least >1 hour, be chronic for >2 months, and refractory to original Enterra GES settings

Exclusion Criteria:

Unable to provide informed consent
Pregnancy
Any other active health problems that would render patient unable to complete the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Gastroparesis patients with abdominal pain.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Abell, MD	University of Louisville	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Louisville		Louisville	Kentucky	40202	United States

Condition Browse Module

MeSH Terms

ID	Term
D015746	Abdominal Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided