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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients seeking temporary gastric electric stimulator devices for drug-refractory gastroparesis between August 2005 and October 2006 who met the inclusion criteria and did not have any of the exclusion criteria were offered access to the research protocol.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No significant events or approaches for the overall study following participant enrollment were performed prior to group assignment.

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.

Participant Flow:   Overall Study
    Gastric Stimactivated Days1-4/Not Activated Days5-8     Gastric StimulationNotActivated Days1-4/Activated Days5-8  
STARTED     28     30  
Completed 1st Intervention     22     23  
Completed 2nd Intervention     22     23  
COMPLETED     22 [1]   23 [2]
NOT COMPLETED     6     7  
Adverse event: lead dislodgement.                 6                 7  
[1] These 22 patients completed the entire 8 day protocol.
[2] These 23 patients completed the entire 8 day protocol.



  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
  Show All Outcome Measures

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 ]
  Hide Outcome Measure 2

Measure Type Primary
Measure Title Symptom of Nausea Associated With Gastroparesis
Measure Description Likert Scale 0-4 (low-high) using a patient reported outcomes tool
Time Frame Study Day 0 (Baseline), Day 3, Day 7  
Safety Issue No  

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 electrogastrogram, 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.

Measured Values
    Gastric Stimactivated Days1-4/Not Activated Days5-8     Gastric StimulationNotActivated Days1-4/Activated Days5-8  
Number of Participants Analyzed  
[units: participants]
  28     30  
Symptom of Nausea Associated With Gastroparesis  
[units: Patient Self-reported Symptom Score]
Mean ± Standard Error
   
Nause Score Day 0     3.27  ± 0.92     3.33  ± 1.03  
Nausea Score Day 3     1.46  ± 1.29     1.67  ± 1.49  
Nausea Score Day 7     2.26  ± 1.18     1.4  ± 1.38  

No statistical analysis provided for Symptom of Nausea Associated With Gastroparesis



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


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: Thomas L. Abell, MD, Professor of Medicine
Organization: University of Mississippi Medical Center
phone: 6019844540
e-mail: tabell@umc.edu


Publications of Results:

Responsible Party: Thomas Abell, MD, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00432835     History of Changes
Other Study ID Numbers: 2004-0185
Study First Received: February 7, 2007
Results First Received: April 11, 2012
Last Updated: November 1, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board