Gastric Pacemaker Implantation for Gastroparesis | NCT00568373

Studies
Gastric Pacemaker Implantation for Gastroparesis

NCT00568373

Sponsor

Indiana University

Status

Withdrawn

Last Update Posted

Mar 5, 2021Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Gastroparesis

Interventions

Enterra Gastric Pacemaker

Countries

Not provided

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

Mar 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

this is not a clinical trial and does not require registration

Expanded Access Info

Start Date

Jun 2007Estimated

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Dec 4, 2007

First Submission Date that Met QC Criteria

Dec 5, 2007

First Posted Date

Dec 6, 2007Estimated

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

Mar 3, 2021

Last Update Posted Date

Mar 5, 2021Actual

Description Module

Brief Summary

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

Detailed Description

Due to HUD status, this protocol is for implant only. This is NOT a clinical trial.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatement	Experimental	All subjects that meet the requirement for gastric stimulator placement	Device: Enterra Gastric Pacemaker

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enterra Gastric Pacemaker	Device	Gastric Pacemaker	Treatement

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018589	Gastroparesis

Ancestor Terms

ID	Term
D013272	Stomach Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010243	Paralysis

Browse Leaves

Not provided

Browse Branches

Not provided