NCT00568373

Brief Summary

Gastric pacemakers and/or temporary gastric stimulators will be implanted in eligible patients.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2007

Longer than P75 for not_applicable

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withdrawn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

Study Start

First participant enrolled

June 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2007

Completed
18 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

18.5 years

First QC Date

December 4, 2007

Last Update Submit

March 3, 2021

Conditions

Gastroparesis

Keywords

GastroparesisGastric electrical stimulator

Study Arms (1)

Treatement

EXPERIMENTAL

All subjects that meet the requirement for gastric stimulator placement

Device: Enterra Gastric Pacemaker

Interventions

Enterra Gastric PacemakerDEVICE

Gastric Pacemaker

Treatement

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Used only if patients have tried and failed conventional treatment ( drug therapy and dietary modification)due to intractable nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All patients who have severe symptoms and have been identified by the PI and Sub I to qualify for the treatment will be under one single group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2007

First Posted

December 6, 2007

Study Start

June 1, 2007

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

March 5, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share