NCT01054794

Brief Summary

This is a prospective study of temporary gastric mucosal electrical stimulation (tGES) in 30 patients with gastroparesis (GP). After a 7 day baseline assessment of symptoms, subjects will have an endoscopically-placed tGES lead implanted into the mucosa of the antrum. This lead is connected to a thin wire that runs up the esophagus and out the nostril, similar to a nasojejunal feeding tube, although much thinner. It is then attached to a programmable battery pack which provides the desired level of stimulation. Patients will then be randomized to 7 days OFF or 7 days ON stimulation in a double-blind fashion. After 7 days, subjects will crossover to the other study arm (ie ON patients will be switched off; OFF patients will be switched on). Symptoms and QoL measures will be assessed at baseline, ON, and OFF periods. Serum ghrelin and other hormones, as well as EGG will be assayed after 6 days in each arm.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 22, 2015

Status Verified

June 1, 2015

Enrollment Period

2 years

First QC Date

January 19, 2010

Last Update Submit

June 19, 2015

Conditions

Gastroparesis

Keywords

GastroparesisGastric Electrical Stimulation

Outcome Measures

Primary Outcomes (1)

  • Changes in patient symptoms during the ON and OFF periods of tGES stimulation.

    daily x 6 days in each phase of study (ON and OFF)

Secondary Outcomes (1)

  • 1. Changes in serum ghrelin and leptin between ON and OFF periods of tGES stimulation in GP patients. 2. Changes in gastric electrical activity between ON and OFF periods of tGES stimulation in GP patients

    Once during each study phase (ON and OFF)

Study Arms (2)

Stimulation ON

ACTIVE COMPARATOR
Device: Gastric mucosal stimulation

Stimulation OFF

SHAM COMPARATOR
Device: Gastric mucosal stimulation

Interventions

Gastric mucosal stimulationDEVICE

The lead is a sterile, 2mm diameter insulated wire (Temporary Transvenous Pacing Lead 6416-200cm, Medtronic, Minneapolis, MN) with 2 electrodes on the distal end. The mucosal stimulation parameters(Current:10 mA; Frequency: 14Hz; Pulse width: 330 ms; Cycle ON: 0.1 s; Cycle OFF: 5 s) are within the range used for standard permanent implanted GES (Enterra therapy) within the serosa and muscle layers of the stomach, and which has been shown to be safe, without any tissue damage.

Stimulation OFFStimulation ON

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 18 or older
  • Existing clinical diagnosis of gastroparesis for at least one year as judged by the study gastroenterologist based on past medical history, clinical symptoms
  • Sufficiently symptomatic at time of proposed study (Minimum total baseline GCSI score of 1.5 or higher)
  • Delayed gastric emptying (\>10% retention at 4 hours) on standard scintigraphic emptying study with patients off narcotics for at least 48 hours. Normal upper endoscopy (with the exception of small bezoars) since the onset of symptoms
  • Medically fit to undergo endoscopy
  • Able and willing to remain in Calgary for the duration of the study (baseline period excepted)
  • Able to provide written informed consent

You may not qualify if:

  • Clinical evidence (including physical exam and/or EKG) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns
  • Current use of anticoagulants, ASA, NSAIDS, clopidogrel, etc. which cannot safely be stopped for up to 5 days prior to the procedure in the opinion of the investigators
  • Bleeding diathesis
  • Severe immunocompromise
  • Physical, mental, or compliance issues which in the opinion of the investigators may prevent the patient from completing the study
  • Pregnant or breastfeeding females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Christopher N Andrews, MD, FRCPC

    University of Calgary, Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 19, 2010

First Posted

January 22, 2010

Study Start

December 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

June 22, 2015

Record last verified: 2015-06

Locations

CA(1)