Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Thomas Abell, MD, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT00432835
First received: February 7, 2007
Last updated: November 1, 2012
Last verified: November 2012
Results First Received: April 11, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Gastroparesis
Intervention: Device: Gastric Electrical Stimulator, Enterra, Medtronics, Inc.

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Gastric Stimactivated Days1-4/Not Activated Days5-8 The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, 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
Gastric StimulationNotActivated Days1-4/Activated Days5-8 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.
Total Total of all reporting groups

Baseline Measures
    Gastric Stimactivated Days1-4/Not Activated Days5-8     Gastric StimulationNotActivated Days1-4/Activated Days5-8     Total  
Number of Participants  
[units: participants]
  28     30     58  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     26     27     53  
>=65 years     2     3     5  
Age  
[units: years]
Mean ± Standard Deviation
  47  ± 13     47  ± 14     47  ± 13  
Gender  
[units: participants]
     
Female     21     26     47  
Male     7     4     11  
Region of Enrollment  
[units: participants]
     
United States     28     30     58  



  Outcome Measures
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1.  Primary:   Symptom of Vomiting Associated With Gastroparesis   [ Time Frame: Study Day 0 (Baseline), Day 3, Day 7 ]

2.  Primary:   Symptom of Nausea Associated With Gastroparesis   [ Time Frame: Study Day 0 (Baseline), Day 3, Day 7 ]

3.  Primary:   Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis   [ Time Frame: Study Day 0 (Baseline), Day 4, Day 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


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