GastroparesisNCT00157755

Enterra Therapy Clinical Study (Gastric Stimulation for Gastroparesis)

A study testing Enterra Therapy in people with Gastroparesis, run by MedtronicNeuro at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This study is to evaluate the safety and effectiveness of gastric stimulation in the reduction of nausea and vomiting in patients with gastroparesis using an approved Humanitarian device. There are two cohorts in this study based on etiology, one for diabetic and one for idiopathic. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Gastroparesis
What is being tested?: Enterra Therapy
Type of treatment: Medical device
How many people: 87 participants
Where: 6 sitesUnited States
Study dates: Jun 2002to Mar 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or Female at least 18 years of age
Diagnosed with gastroparesis due to diabetes or an unknown cause (idiopathic)
Have tried prokinetic (help the stomach empty quicker) and antiemetic (help decrease symptoms of nausea and vomiting) medications for a minimum of one month, unless you're unable to take these types of medications
Have symptoms of gastroparesis that have required treatment for at least one year
Experience at least 7 episodes of vomiting during a seven consecutive day period on a 28-day diary
Willing and able to completely and accurately fill out a diary and questionnaires throughout the study
Have gastric retention of greater than 10% at four hours, or greater than 60% at two hours (if unable to complete the four-hour test) on a Gastric Emptying Test (GET)

Who cannot join

Gastroparesis caused by a specific diagnosed illness other than diabetes
Current eating disorder or diagnosed swallowing disorder
Previous stomach surgeries
Taking narcotic pain-relievers daily for abdominal pain
Diagnosed with drug or alcohol dependency within 1 year before the study
Life expectancy less than one year

Show all 12Show fewer

Have other implantable devices such as pacemakers
Pregnancy or planned pregnancy
Plan to receive diathermy treatment
Have had radiation therapy of the upper abdomen
Plan on having an MRI performed
Currently participating in another investigational device or drug study

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Contact Medtronic for exact location
Anderson, Indiana
Contact Medtronic for exact location
Kansas City, Kansas
Contact Medtronic for exact location
Louisville, Kentucky
Contact Medtronic for exact location
Philadelphia, Pennsylvania
Contact Medtronic for exact location
San Francisco, California
Contact Medtronic for exact location
Washington D.C., District of Columbia

Other trials in United States

About this study

Official title: Gastric Stimulation for Vomiting, Nausea and Related Symptoms Associated With Gastroparesis Using Enterra® Gastric Stimulation System

A maximum of 150 patients (75 diabetic and 75 idiopathic) from up to 15 centers in the United States will be followed closely for twelve months and then once a year after that until the study closes.

If you are someone suffering with symptoms of gastroparesis despite trying oral medications, you may be eligible to participate in a clinical study using a surgically implanted gastric stimulator.

Conditions: Gastroparesis
Being tested: Enterra Therapy
Keywords: Nausea and Vomiting
Medical subject headings: Gastroparesis, Nausea, Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enterra TherapyDevice
Gastric electrical stimulation using Enterra Therapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Reduction in Frequency of Weekly Vomiting Episodes When the Device is Turned ON, Relative to When the Device is Turned OFF
Diaries were used to record daily vomiting episodes for 28 days prior to each office follow-up visit. The weekly vomiting frequency (WVF) was based on the average number of weekly vomiting episodes recorded in the patient diary. The percent reduction is calculated as ((WVF during OFF - WVF during ON)/ (WVF during OFF))*100%. A positive reduction represents an improvement in WVF when the device was ON.
Measured: 4.5 months and 7.5 months

Secondary outcomes (2)

Percent Reduction in Symptom Score When the Device is Turned ON, Relative to When the Device is Turned OFF
A symptom interview was conducted at each visit to assess vomiting, nausea, early satiety, bloating, postprandial fullness, epigastric pain and epigastric burning. The scale for each symptom ranges from 0 to 4, with 0 being absence of symptoms and 4 being extremely frequent (≥ 7 episodes per week). Total symptom score (TSS) is the sum of the individual frequency symptom scores. The percent reduction is calculated as ((TSS during OFF - TSS during ON)/ (TSS during OFF))*100%. A positive reduction represents an improvement in TSS when the device was ON.
Measured: 4.5 months and 7.5 months
Percent Reduction in the Frequency of Weekly Vomiting Episodes at 12 Months Compared to Baseline
Diaries were used to record daily vomiting episodes for 28 days prior to each office follow-up visit. The weekly vomiting frequency (WVF) was based on the average number of weekly vomiting episodes recorded in the patient diary. The percent reduction is calculated as ((WVF at baseline - WVF at 12 months)/ (WVF at baseline))*100%. A positive reduction represents an improvement in WVF at 12 months.
Measured: baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2002Mar 2009

First posted12 Sep 2005 (estimated)
Study startJun 2002
Primary completionDec 2008
Study completionMar 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.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00157755
Sponsor's protocol ID: NDHF0025-70006
Status last verified: Dec 2009
First submitted: 8 Sep 2005
Last updated: 10 Mar 2010
Results posted: Yes, on ClinicalTrials.gov

Publications

McCallum RW, Snape W, Brody F, Wo J, Parkman HP, Nowak T. Gastric electrical stimulation with Enterra therapy improves symptoms from diabetic gastroparesis in a prospective study. Clin Gastroenterol Hepatol. 2010 Nov;8(11):947-54; quiz e116. doi: 10.1016/j.cgh.2010.05.020. Epub 2010 Jun 9.
PubMed 20538073

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Gastric Focused Ultrasound Stimulation
Gastroparesis, Delayed Gastric Emptying
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
Not yet recruiting
Stomach-Partitioning Versus Conventional Gastrojejunostomy for Malignant Gastric Outlet Obstruction: A Multicenter Randomized Controlled Trial
Gastric Cancer, Gastric Outlet Obstruction
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

All Gastroparesis trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Gastric Stimulation for Vomiting, Nausea and Related Symptoms Associated With Gastroparesis Using Enterra® Gastric Stimulation System
ClinicalTrials.gov ID: NCT00157755
Acronym / sponsor ID: NDHF0025-70006
Conditions: Gastroparesis
Keywords: Nausea and Vomiting
Study type: Interventional
Recruitment status: Terminated
Enrolment: 87 participants (actual)
Lead sponsor: MedtronicNeuroIndustry (pharma, biotech, devices)
Study start: Jun 2002
Primary completion: Dec 2008 (actual)
Study completion: Mar 2009 (actual)
First posted: 12 Sep 2005 (estimated)
Results: Posted 10 Mar 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A maximum of 150 patients (75 diabetic and 75 idiopathic) from up to 15 centers in the United States will be followed closely for twelve months and then once a year after that until the study closes.

If you are someone suffering with symptoms of gastroparesis despite trying oral medications, you may be eligible to participate in a clinical study using a surgically implanted gastric stimulator.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male or Female at least 18 years of age
Diagnosed with gastroparesis due to diabetes or an unknown cause (idiopathic)
Have tried prokinetic (help the stomach empty quicker) and antiemetic (help decrease symptoms of nausea and vomiting) medications for a minimum of one month, unless you're unable to take these types of medications
Have symptoms of gastroparesis that have required treatment for at least one year
Experience at least 7 episodes of vomiting during a seven consecutive day period on a 28-day diary

Key exclusion criteria (12 listed)

Gastroparesis caused by a specific diagnosed illness other than diabetes
Current eating disorder or diagnosed swallowing disorder
Previous stomach surgeries
Taking narcotic pain-relievers daily for abdominal pain
Diagnosed with drug or alcohol dependency within 1 year before the study

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 TherapyGastric electrical stimulation using Enterra Therapy.	Device	–

Primary outcome

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
Diaries were used to record daily vomiting episodes for 28 days prior to each office follow-up visit. The weekly vomiting frequency (WVF) was based on the average number of weekly vomiting episodes recorded in the patient diary. The percent reduction is calculated as ((WVF during OFF - WVF during ON)/ (WVF during OFF))*100%. A positive reduction represents an improvement in WVF when the device was ON.

2 secondary outcomes

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
Percent Reduction in the Frequency of Weekly Vomiting Episodes at 12 Months Compared to Baseline
Time frame: baseline and 12 months

Results and safety

Results posted to the registry on 10 Mar 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diabetic: ON First, Then OFF	26	24
Diabetic: OFF First, Then ON	19	15
Diabetic: Not Randomized	10	3
Idiopathic: ON First, Then OFF	15	11
Idiopathic: OFF First, Then ON	12	10
Idiopathic: Not Randomized	5	0

Primary outcome: 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. Median (Full Range). Unit: percent reduction in WVF

Measure	Diabetic n = 32	Idiopathic n = 20
Value	0 (-300 to 100)	17.3 (-450 to 100)

Diabetic: p = 0.215, Wilcoxon Signed Rank Test
Idiopathic: p = 1.0, Wilcoxon Signed Rank Test

Population analysed: The analysis population included subjects who were randomized, completed the study through the end of the blinded crossover period and provided evaluable measurements.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diabetic	8 of 55 (14.5%)	13 of 55 (23.6%)	Not reported
Idiopathic	4 of 32 (12.5%)	9 of 32 (28.1%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20538073McCallum RW, Snape W, Brody F, Wo J, Parkman HP, Nowak T. Gastric electrical stimulation with Enterra therapy improves symptoms from diabetic gastroparesis in a prospective study. Clin Gastroenterol Hepatol. 2010 Nov;8(11):947-54; quiz e116. doi: 10.1016/j.cgh.2010.05.020. Epub 2010 Jun 9.

Related trials for Gastroparesis

Recruiting
Gastric Focused Ultrasound Stimulation
Gastroparesis, Delayed Gastric Emptying
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
Not yet recruiting
Stomach-Partitioning Versus Conventional Gastrojejunostomy for Malignant Gastric Outlet Obstruction: A Multicenter Randomized Controlled Trial
Gastric Cancer, Gastric Outlet Obstruction
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.

Darin R Lerew, PhD study director

Medtronic

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Enterra Therapy in people with Gastroparesis, run by MedtronicNeuro at 6 sites 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 7 inclusion and 12 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: stopped early, as of the sponsor's last update on 10 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 10 Mar 2010). 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?

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). 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 NCT00157755, 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 10 Mar 2010.