Gastric StasisNCT00595621
Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis
A study testing Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1) in people with Gastric Stasis, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
Investigate the safety and efficacy of multi-channel gastric electrical stimulation in the treatment of patients with severe diabetic gastroparesis refractory to standard therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Stasis
- What is being tested?
- Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Jun 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe nausea and vomiting for at least 6 months
- Documented delayed gastric emptying
- Failed extensive medical treatment
Who cannot join
- Previous gastric surgery
- Pregnancy or planned pregnancy
- Primary eating or swallowing disorders
- Scheduled or planned MRI testing
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Investigate the safety and efficacy of multi-channel gastric electrical stimulation in the treatment of patients with severe diabetic gastroparesis refractory to standard therapy.
Read the detailed description
Evaluation of severe symptom control of nausea, vomiting, postprandial fullness, early satiety, bloating and discomfort related to drug refractory gastroparesis present as a GI complication in diabetic patients. External gastric pacemaker system will be placed at the same time of implantation of Enterra (internal gastric stimulator-permanent device) to assess symptoms, quality of life improvement and investigate the changes in gastric emptying time in diabetic gastroparesis.
- Conditions
- Gastric Stasis
- Being tested
- Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1)
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1)Device
Multi-Channel Phased Gastric Pacemaker (MGP-1)
| Study group | Role | What they receive |
|---|---|---|
| MGP-1 ON | Active comparator | Experimental Pacemaker on for 6 weeks Receives: Device: Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1) |
| MGP-1 OFF | Active comparator | Experimental Pacemaker on or off for 4 weeks Receives: Device: Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Slow Wave Entrainment
Participants were monitored for up to 3 months. Measure is the percent of normal slow waves (2-4 cpm) generated by MGP-1 device while it was ON or OFF
Measured: 12 Weeks
Secondary outcomes (5)
The Percent (Percentage) of Gastric Retention of a Solid Meal
The retention of a study meal was measured at baseline, 1,2,3 and 4 hours of the test. The percent of food retained in a stomach at 4 hours was compared when MGP-1 was ON and OFF.
Measured: 12 Weeks
Severity of Gastroparetic Symptoms
Measure represents change in symptom severity as measured by a self assessment Symptom Interview Form evaluating severity of vomiting, nausea, early satiety, bloating, postprandial fullness, epigastric pain, and epigastric burning. Symptoms were rated from 0 - absence of symptom to 4 - extremely severe. The overall score was calculated from the sum of seven symptom sub-scores with a total possible score range of 0 - absence of all symptoms to 28 - all symptoms extremely severe.
Measured: 12 weeks
Changes in Quality of Life (QoL) Assessment (Physical (P) and Mental (M))
Measure represents percentage change from baseline to end of study. QoL measured using the Short Form Health Survey (SF-36) questionnaire. The SF-36 is a generic measure of QoL. Physical QoL (Physical Component Summary; PCS) and emotional QoL (Mental Component summary; MCS) scale components of the survey used for outcome. Scores range from 0 to 100 with lower scores indicating more disability and higher scores less disability.
Measured: 12 Weeks
Changes in Hemoglobin A1c (HbA1c) Level
HbA1c was evaluated at the baseline and after completion of all the phases of the study
Measured: 12 Weeks
Changes in Hospital Admissions
Measured by days of hospitalization per patient. Number of days of hospitalization was recorded at baseline and after completion of all phases of the study.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startFeb 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastric StasisStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- GI Stimulation, Inc., National Institutes of Health (NIH), American Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Richard W. McCallum, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595621
- Sponsor's protocol ID
- 9459
- Status last verified
- May 2019
- First submitted
- 7 Jan 2008
- Last updated
- 31 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis
- ClinicalTrials.gov ID
- NCT00595621
- Acronym / sponsor ID
- 9459
- Conditions
- Gastric Stasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- GI Stimulation, Inc., National Institutes of Health (NIH), American Diabetes Association
- Study start
- Feb 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Posted 31 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigate the safety and efficacy of multi-channel gastric electrical stimulation in the treatment of patients with severe diabetic gastroparesis refractory to standard therapy.
Detailed description
Evaluation of severe symptom control of nausea, vomiting, postprandial fullness, early satiety, bloating and discomfort related to drug refractory gastroparesis present as a GI complication in diabetic patients. External gastric pacemaker system will be placed at the same time of implantation of Enterra (internal gastric stimulator-permanent device) to assess symptoms, quality of life improvement and investigate the changes in gastric emptying time in diabetic gastroparesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MGP-1 ON | Active comparator | Device: Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1)Experimental Pacemaker on for 6 weeks |
| MGP-1 OFF | Active comparator | Device: Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1)Experimental Pacemaker on or off for 4 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Severe nausea and vomiting for at least 6 months
- Documented delayed gastric emptying
- Failed extensive medical treatment
Key exclusion criteria (4 listed)
- Previous gastric surgery
- Pregnancy or planned pregnancy
- Primary eating or swallowing disorders
- Scheduled or planned MRI testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1)Multi-Channel Phased Gastric Pacemaker (MGP-1) | Device | MGP-1 OFF, MGP-1 ON |
Primary outcome
Percentage of Slow Wave Entrainment
Time frame: 12 Weeks
Participants were monitored for up to 3 months. Measure is the percent of normal slow waves (2-4 cpm) generated by MGP-1 device while it was ON or OFF
5 secondary outcomes
The Percent (Percentage) of Gastric Retention of a Solid Meal
Time frame: 12 Weeks
Severity of Gastroparetic Symptoms
Time frame: 12 weeks
Changes in Quality of Life (QoL) Assessment (Physical (P) and Mental (M))
Time frame: 12 Weeks
Changes in Hemoglobin A1c (HbA1c) Level
Time frame: 12 Weeks
Changes in Hospital Admissions
Time frame: 12 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
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Not yet recruiting
Stomach-Partitioning Versus Conventional Gastrojejunostomy for Malignant Gastric Outlet Obstruction: A Multicenter Randomized Controlled Trial
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Recruiting
To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
Type 1 Diabetes, Gastroparesis Due to Diabetes Mellitus Type I
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard W. McCallum, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1) in people with Gastric Stasis, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Slow Wave Entrainment (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2019.