GastroparesisPhase 3NCT00432835
Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis
A Phase 3 study testing Gastric Electrical Stimulator, Enterra, Medtronics, Inc. in people with Gastroparesis, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
The purpose of this research is to determine if temporary gastric electrical stimulation will help improve symptoms of gastroparesis (abnormal stomach emptying). We hypothesize that when the device is ON, Gastrointestinal symptoms will decrease by at least 50% from baseline. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Gastric Electrical Stimulator, Enterra, Medtronics, Inc.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Nov 2007
- Phase
- Phase 3
- 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
- Sex: Male of Female
- Age Range: 18 to 70 inclusive
- Patients with GP of diabetic, surgically related or idiopathic etiology.
- Symptoms of GP for >/= 1 year.
- Refractory or intolerant to antiemetic drug classes (antihistamines and phenothiazines, serotonin receptor antagonists, dopamine receptor antagonists)
- Chronic vomiting and/or nausea with 7 or more episodes per week for either symptom irrespective of GET values.
- The patient is willing and able to provide informed consent.
- The patient is willing and able to return for required follow-up visits.
Who cannot join
- Patients < 18 or >70 years in age.
- Patients with an active infection of any kind.
- Patients who the investigator determines are not candidates for endoscopic procedures.
- Women who are pregnant
- Inability or unwillingness to provide informed consent
- Unwilling or unable to return for required follow-up visits and examinations.
- Patients who are currently enrolled in another investigation of a medical device or drug.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Official title: Double-Blind Placebo-Controlled Cross-Over Design With Wash-Out for Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis
The purpose of this research is to determine if temporary gastric electrical stimulation will help improve symptoms of gastroparesis (abnormal stomach emptying). We hypothesize that when the device is ON, Gastrointestinal symptoms will decrease by at least 50% from baseline.
Read the detailed description
Gastric Electrical Stimulation is an established treatment for drug-refractory patients who have the symptoms of gastroparesis/gastropathy. The symptoms of GP are nausea, vomiting, anorexia/early satiety, bloating/distention and abdominal pain and are classically associated with delayed gastric emptying of solids. The technique of GES was first used, in a patient seen at University of Tennesse-Memphis in 1993 and has undergone several clinical trials, particularly the GEMS trial, a feasibility trial starting in 1995 and the WAVESS trial, a double-blind trial begun in 1997. Both were international trials, showing promising results, and both have been published in the last 2 years. However, a number of issues related to who would benefit the most from Gastric Electrical Stimulation therapy have emerged. Among these issues are whether patients with etiologies other than diabetic or idiopathic gastroparesis, such as post-surgical gastropathy, which is often related to rapid, not delayed gastric emptying could be helped.
Most recently a technique for the temporary placement of a Gastric Electrical Stimulation electrode in the stomach with an upper endoscope, combined with an external Gastric Electrical Stimulation device, has been tried and validated, first at UAMS in Little Rock, AR, beginning in 2001 and more recently here at UMMC, beginning later in 2001 and up until the present time. Using the technique of temporary gastric electrical stimulation, we have been able to demonstrate that TempStim can quickly demonstrate (in a manner of days) that a patient will respond to temporary GES, as quantified by a decrease in GI total symptoms and an improvement and normalization in solid gastric emptying.
- Conditions
- Gastroparesis
- Being tested
- Gastric Electrical Stimulator, Enterra, Medtronics, Inc.
- Keywords
- Nausea, Vomiting, Delayed gastric emptying, Diabetes Mellitus, Post-Surgical, Idiopathic
- Medical subject headings
- Gastroparesis, Nausea, Vomiting, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric Electrical Stimulator, Enterra, Medtronics, Inc.Device
Also called No other name currently exists.
All patients received a GES electrode, endoscopically placed and connected to an external device at baseline. The device was turned ON to provide 72 continuous hours of active stimulation and OFF to deactivate stimulation
| Study group | Role | What they receive |
|---|---|---|
| Gastric Stimulation Days1-4/Sham5-8 | Active comparator | The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal EGG, 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 Receives: Device: Gastric Electrical Stimulator, Enterra, Medtronics, Inc. |
| Sham1-4/Gastric Stimulation Days5-8 | Active comparator | 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. Receives: Device: Gastric Electrical Stimulator, Enterra, Medtronics, Inc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom of Vomiting Associated With Gastroparesis
Likert Scale 0-4 (low-high) using a patient reported outcomes tool
Measured: Study Day 0 (Baseline), Day 3, Day 7
Symptom of Nausea Associated With Gastroparesis
Likert Scale 0-4 (low-high) using a patient reported outcomes tool
Measured: Study Day 0 (Baseline), Day 3, Day 7
Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis
Transit time of a radio-labeled meal through the stomach, measured by scintigraphy for %contents remaining in the stomach at 1 hour, 2 hours, and 4 hours. GET measures were obtained at baseline, during the period allowed for 'washout', and on the final study day.
Measured: Study Day 0 (Baseline), Day 4, Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2007 (estimated)
- Study startAug 2005
- Primary completionOct 2006
- Study completionNov 2007
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Thomas Abell, MD, University of Mississippi Medical Center
- Investigators
- Thomas L Abell, MD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432835
- Sponsor's protocol ID
- 2004-0185
- Status last verified
- Nov 2012
- First submitted
- 7 Feb 2007
- Last updated
- 3 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Abell TL, Johnson WD, Kedar A, Runnels JM, Thompson J, Weeks ES, Minocha A, Griswold ME. A double-masked, randomized, placebo-controlled trial of temporary endoscopic mucosal gastric electrical stimulation for gastroparesis. Gastrointest Endosc. 2011 Sep;74(3):496-503.e3. doi: 10.1016/j.gie.2011.05.022.
PubMed 21872708
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Placebo-Controlled Cross-Over Design With Wash-Out for Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis
- ClinicalTrials.gov ID
- NCT00432835
- Acronym / sponsor ID
- 2004-0185
- Conditions
- Gastroparesis
- Keywords
- Nausea, Vomiting, Delayed gastric emptying, Diabetes Mellitus, Post-Surgical, Idiopathic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Aug 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 8 Feb 2007 (estimated)
- Results
- Posted 3 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to determine if temporary gastric electrical stimulation will help improve symptoms of gastroparesis (abnormal stomach emptying). We hypothesize that when the device is ON, Gastrointestinal symptoms will decrease by at least 50% from baseline.
Detailed description
Gastric Electrical Stimulation is an established treatment for drug-refractory patients who have the symptoms of gastroparesis/gastropathy. The symptoms of GP are nausea, vomiting, anorexia/early satiety, bloating/distention and abdominal pain and are classically associated with delayed gastric emptying of solids. The technique of GES was first used, in a patient seen at University of Tennesse-Memphis in 1993 and has undergone several clinical trials, particularly the GEMS trial, a feasibility trial starting in 1995 and the WAVESS trial, a double-blind trial begun in 1997. Both were international trials, showing promising results, and both have been published in the last 2 years. However, a number of issues related to who would benefit the most from Gastric Electrical Stimulation therapy have emerged. Among these issues are whether patients with etiologies other than diabetic or idiopathic gastroparesis, such as post-surgical gastropathy, which is often related to rapid, not delayed gastric emptying could be helped.
Most recently a technique for the temporary placement of a Gastric Electrical Stimulation electrode in the stomach with an upper endoscope, combined with an external Gastric Electrical Stimulation device, has been tried and validated, first at UAMS in Little Rock, AR, beginning in 2001 and more recently here at UMMC, beginning later in 2001 and up until the present time. Using the technique of temporary gastric electrical stimulation, we have been able to demonstrate that TempStim can quickly demonstrate (in a manner of days) that a patient will respond to temporary GES, as quantified by a decrease in GI total symptoms and an improvement and normalization in solid gastric emptying.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric Stimulation Days1-4/Sham5-8 | Active comparator | Device: Gastric Electrical Stimulator, Enterra, Medtronics, Inc.The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal EGG, 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 |
| Sham1-4/Gastric Stimulation Days5-8 | Active comparator | Device: Gastric Electrical Stimulator, Enterra, Medtronics, Inc.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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Sex: Male of Female
- Age Range: 18 to 70 inclusive
- Patients with GP of diabetic, surgically related or idiopathic etiology.
- Symptoms of GP for >/= 1 year.
- Refractory or intolerant to antiemetic drug classes (antihistamines and phenothiazines, serotonin receptor antagonists, dopamine receptor antagonists)
Key exclusion criteria (7 listed)
- Patients < 18 or >70 years in age.
- Patients with an active infection of any kind.
- Patients who the investigator determines are not candidates for endoscopic procedures.
- Women who are pregnant
- Inability or unwillingness to provide informed consent
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 |
|---|---|---|
| Gastric Electrical Stimulator, Enterra, Medtronics, Inc.Also: No other name currently exists.All patients received a GES electrode, endoscopically placed and connected to an external device at baseline. The device was turned ON to provide 72 continuous hours of active stimulation and OFF to deactivate stimulation | Device | Gastric Stimulation Days1-4/Sham5-8, Sham1-4/Gastric Stimulation Days5-8 |
Primary outcome
Symptom of Vomiting Associated With Gastroparesis
Time frame: Study Day 0 (Baseline), Day 3, Day 7
Likert Scale 0-4 (low-high) using a patient reported outcomes tool
Symptom of Nausea Associated With Gastroparesis
Time frame: Study Day 0 (Baseline), Day 3, Day 7
Likert Scale 0-4 (low-high) using a patient reported outcomes tool
Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis
Time frame: Study Day 0 (Baseline), Day 4, Day 8
Transit time of a radio-labeled meal through the stomach, measured by scintigraphy for %contents remaining in the stomach at 1 hour, 2 hours, and 4 hours. GET measures were obtained at baseline, during the period allowed for 'washout', and on the final study day.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21872708Abell TL, Johnson WD, Kedar A, Runnels JM, Thompson J, Weeks ES, Minocha A, Griswold ME. A double-masked, randomized, placebo-controlled trial of temporary endoscopic mucosal gastric electrical stimulation for gastroparesis. Gastrointest Endosc. 2011 Sep;74(3):496-503.e3. doi: 10.1016/j.gie.2011.05.022.
- Pub Med abstract of study as reported in "Gastrointestinal Endoscopy"Link provided by the sponsor.
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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.
Thomas L Abell, MD principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gastric Electrical Stimulator, Enterra, Medtronics, Inc. in people with Gastroparesis, run by University of Mississippi 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 8 inclusion and 7 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 3 Dec 2012. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2012). 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?
Symptom of Vomiting Associated With Gastroparesis (time frame: Study Day 0 (Baseline), Day 3, Day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00432835, which also lists 1 linked publication.
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 3 Dec 2012.