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Enterra Therapy Clinical Study (Gastric Stimulation for Gastroparesis)

This study has been terminated.
Sponsor:
Information provided by:
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00157755
First received: September 8, 2005
Last updated: February 23, 2010
Last verified: December 2009
Results First Received: December 18, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Gastroparesis
Intervention: Device: Enterra Therapy

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Diabetic: ON First, Then OFF This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. During the crossover phase of the study, this subject had the device ON for three months, followed by device OFF for three months.
Diabetic: OFF First, Then ON This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. During the crossover phase of the study, this subject had the device OFF for three months, followed by device ON for three months.
Diabetic: Not Randomized This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. These subjects exited the study prior to randomization at 1.5 months.
Idiopathic: ON First, Then OFF This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. During the crossover phase of the study, this subject had the device ON for three months, followed by device OFF for three months.
Idiopathic: OFF First, Then ON This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. During the crossover phase of the study, this subject had the device OFF for three months, followed by device ON for three months.
Idiopathic: Not Randomized This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. These subjects exited the study prior to randomization at 1.5 months.

Participant Flow:   Overall Study
    Diabetic: ON First, Then OFF     Diabetic: OFF First, Then ON     Diabetic: Not Randomized     Idiopathic: ON First, Then OFF     Idiopathic: OFF First, Then ON     Idiopathic: Not Randomized  
STARTED     26     19     10     15     12     5  
COMPLETED     24 [1]   15 [1]   3 [1]   11 [1]   10 [1]   0 [1]
NOT COMPLETED     2     4     7     4     2     5  
Death                 2                 3                 3                 2                 0                 0  
Lost to Follow-up                 0                 0                 1                 0                 0                 0  
Withdrawal by Subject                 0                 0                 1                 1                 1                 2  
Explant due to infection                 0                 0                 1                 0                 0                 0  
Medical reason                 0                 0                 1                 1                 0                 0  
Study site closure                 0                 1                 0                 0                 0                 0  
Subject non-compliance                 0                 0                 0                 0                 0                 1  
Study completion                 0                 0                 0                 0                 1                 2  
[1] Subjects finished 12-month follow-up.



  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
Diabetic This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
Idiopathic This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
Total Total of all reporting groups

Baseline Measures
    Diabetic     Idiopathic     Total  
Number of Participants  
[units: participants]
  55     32     87  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     55     32     87  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  38.3  ± 9.8     39.4  ± 10.4     38.7  ± 10.0  
Gender  
[units: participants]
     
Female     36     26     62  
Male     19     6     25  
Region of Enrollment  
[units: participants]
     
United States     55     32     87  



  Outcome Measures
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1.  Primary:   Percent Reduction in Frequency of Weekly Vomiting Episodes When the Device is Turned ON, Relative to When the Device is Turned OFF   [ Time Frame: 4.5 months and 7.5 months ]

2.  Secondary:   Percent Reduction in Symptom Score When the Device is Turned ON, Relative to When the Device is Turned OFF   [ Time Frame: 4.5 months and 7.5 months ]

3.  Secondary:   Percent Reduction in the Frequency of Weekly Vomiting Episodes at 12 Months Compared to Baseline   [ Time Frame: baseline and 12 months ]

4.  Other Pre-specified:   Percentage of Responders at 12 Months   [ Time Frame: baseline and 12 months ]

5.  Other Pre-specified:   Change in Symptom Score at 12 Months Compared to Baseline.   [ Time Frame: baseline and 12 months ]

6.  Other Pre-specified:   Change in Quality of Life (QOL) at 12 Months Compared to Baseline (Physical Component Summary)   [ Time Frame: baseline and 12 months ]

7.  Other Pre-specified:   Change in Quality of Life at 12 Months Compared to Baseline (Mental Component Summary)   [ Time Frame: baseline and 12 months ]

8.  Other Pre-specified:   Change in Gastric Emptying Results at 12 Months Compared to Baseline (2 Hours)   [ Time Frame: baseline and 12 months ]

9.  Other Pre-specified:   Change in Gastric Emptying Results at 12 Months Compared to Baseline (4 Hours)   [ Time Frame: baseline and 12 months ]


  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
Early termination of the study impacted the ability to analyze the primary endpoint and secondary endpoint 1 for the idiopathic arm of the study. The minimum sample size for analysis of these endpoints was 32 subjects.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Clinical Program Manager
Organization: Medtronic Neuromodulation
phone: 763-526-8172
e-mail: medtronicneurotrials@medtronic.com


No publications provided by MedtronicNeuro

Publications automatically indexed to this study:

Responsible Party: Darin Lerew, Sr. Clinical Manager, Medtronic Neuromodulation
ClinicalTrials.gov Identifier: NCT00157755     History of Changes
Other Study ID Numbers: NDHF0025-70006
Study First Received: September 8, 2005
Results First Received: December 18, 2009
Last Updated: February 23, 2010
Health Authority: United States: Food and Drug Administration