Temporary Gastric Electrical Stimulation for Gastroparesis

NCT ID: NCT01054794

Last Updated: 2015-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2011-12-31

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.

Conditions

Gastroparesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Stimulation ON

Group Type: ACTIVE_COMPARATOR

Gastric mucosal stimulation

Intervention Type: DEVICE

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 OFF

Group Type: SHAM_COMPARATOR

Gastric mucosal stimulation

Intervention Type: DEVICE

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.

Interventions

Gastric mucosal stimulation

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Christopher Andrews

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher N Andrews, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Calgary, Faculty of Medicine

Locations

University of Calgary

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

TS01

Identifier Type: -

Identifier Source: org_study_id