Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis

NCT00432835 | Completed Phase 3 Results DMC

• 1 other identifier: 2004-0185
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to determine if temporary gastric electrical stimulation will help improve symptoms of gastroparesis (abnormal stomach emptying). We hypothesize that when the device is ON, Gastrointestinal symptoms will decrease by at least 50% from baseline.

Conditions

Gastroparesis

Keywords

Nausea; Vomiting; Delayed gastric emptying; Diabetes Mellitus; Post-Surgical; Idiopathic

Outcome Measures

Primary Outcomes (3)

• Symptom of Vomiting Associated With Gastroparesis

  Likert Scale 0-4 (low-high) using a patient reported outcomes tool

  Study Day 0 (Baseline), Day 3, Day 7

• Symptom of Nausea Associated With Gastroparesis

  Likert Scale 0-4 (low-high) using a patient reported outcomes tool

  Study Day 0 (Baseline), Day 3, Day 7

• Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis

  Transit time of a radio-labeled meal through the stomach, measured by scintigraphy for %contents remaining in the stomach at 1 hour, 2 hours, and 4 hours. GET measures were obtained at baseline, during the period allowed for 'washout', and on the final study day.

  Study Day 0 (Baseline), Day 4, Day 8

Study Arms (2)

Gastric Stimulation Days1-4/Sham5-8

ACTIVE COMPARATOR

The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal EGG, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days

Device: Gastric Electrical Stimulator, Enterra, Medtronics, Inc.

Sham1-4/Gastric Stimulation Days5-8

ACTIVE COMPARATOR

The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal EGG, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.

Device: Gastric Electrical Stimulator, Enterra, Medtronics, Inc.

Interventions

Gastric Electrical Stimulator, Enterra, Medtronics, Inc. DEVICE

All patients received a GES electrode, endoscopically placed and connected to an external device at baseline. The device was turned ON to provide 72 continuous hours of active stimulation and OFF to deactivate stimulation

Also known as: No other name currently exists.

Gastric Stimulation Days1-4/Sham5-8; Sham1-4/Gastric Stimulation Days5-8

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sex: Male of Female
• Age Range: 18 to 70 inclusive
• Patients with GP of diabetic, surgically related or idiopathic etiology.
• Symptoms of GP for \>/= 1 year.
• Refractory or intolerant to antiemetic drug classes (antihistamines and phenothiazines, serotonin receptor antagonists, dopamine receptor antagonists)
• Chronic vomiting and/or nausea with 7 or more episodes per week for either symptom irrespective of GET values.
• The patient is willing and able to provide informed consent.
• The patient is willing and able to return for required follow-up visits.

You may not qualify if:

• Patients \< 18 or \>70 years in age.
• Patients with an active infection of any kind.
• Patients who the investigator determines are not candidates for endoscopic procedures.
• Women who are pregnant
• Inability or unwillingness to provide informed consent
• Unwilling or unable to return for required follow-up visits and examinations.
• Patients who are currently enrolled in another investigation of a medical device or drug.

Sponsors & Collaborators

• University of Mississippi Medical Center: lead
• Medtronic: collaborator

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (1)

• Abell TL, Johnson WD, Kedar A, Runnels JM, Thompson J, Weeks ES, Minocha A, Griswold ME. A double-masked, randomized, placebo-controlled trial of temporary endoscopic mucosal gastric electrical stimulation for gastroparesis. Gastrointest Endosc. 2011 Sep;74(3):496-503.e3. doi: 10.1016/j.gie.2011.05.022.

  PMID: 21872708 RESULT

Related Links

• Pub Med abstract of study as reported in "Gastrointestinal Endoscopy"

MeSH Terms

Conditions

Gastroparesis; Nausea; Vomiting; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

New lead implantation techniques now minimize dislodgment (only adverse effect); Parallel, non-crossover protocol will address any carry-over effect after tGES activation OFF; stratification for baseline mucosal EGG and medications may be useful.

Results Point of Contact

• Title: Thomas L. Abell, MD, Professor of Medicine
• Organization: University of Mississippi Medical Center

tabell@umc.edu

6019844540

Study Officials

• Thomas L Abell, MD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor of Medicine, Director, Division of Digestive Diseases

Study Record Dates

• First Submitted: February 7, 2007
• First Posted: February 8, 2007
• Study Start: August 1, 2005
• Primary Completion: October 1, 2006
• Study Completion: November 1, 2007
• Last Updated: December 3, 2012
• Results First Posted: December 3, 2012

Record last verified: 2012-11

Locations

US (1)