GastroparesisPhase 4EnterraNCT00556166
Enterra Therapy Gastric Stimulation System
A Phase 4 study testing Enterra Therapy Gastric Stimulator in people with Gastroparesis, run by Columbia University at 1 site in United States.
Trial summary
Enterra Therapy Gastric Simulation System (Enterra Therapy) is indicated for the treatment of patients with long term, uncontrolled (not helped by medication) nausea and vomiting from gastroparesis of diabetic or idiopathic origin. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Enterra Therapy Gastric Stimulator
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Sep 2008
- Phase
- Phase 4
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic(long term, lasting greater than 3 months)
- Intractable (drug refractory, failed medical management with prokinetic and antiemetic drugs
- Failed dietary modifications, and/or requiring enteral feeding) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology
Who cannot join
- Only patients whom the physician determines are not a candidate for surgical procedures and/or anesthesia due to physical or mental conditions will be excluded. This includes pregnant women, anyone unable to tolerate general anesthesia, and uncorrectable coagulopathy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University College of Physicians and Surgeons
New York, New York, 10032
About this study
Enterra Therapy Gastric Simulation System (Enterra Therapy) is indicated for the treatment of patients with long term, uncontrolled (not helped by medication) nausea and vomiting from gastroparesis of diabetic or idiopathic origin.
In March 2000, the Food and Drug Administration (FDA) gave approval of a humanitarian Device Exemption (HDE) of a Humanitarian Use Device (HUD) for Enterra Therapy Gastric electrical (GES) Simulation System. Although, there is evidence that suggests the use of Enterra Therapy System probably helps patients, symptoms, the FDA's HDE approval indicates that the helpfulness of this therapy has not been proven. Physicians at Columbia University Medical Center hope to prove the helpfulness of this device.
Read the detailed description
Gastroparesis is a debilitating disease in which patients suffer from a number of upper gastrointestinal (GI) symptoms including nausea, vomiting, early satiety, bloating, postprandial fullness, epigastric pain and burning, and cardiac pain and burning. Severe symptoms, particularly vomiting and nausea, can significantly impair a patients daily activities and quality of life.
Current medical practice for the treatment and/or management of gastroparesis consists of dietary modifications, drug therapies, enteral feeding, parenteral feeding and surgery. These treatments are successful for some patients, but have significant drawbacks. Patients may initially be treated with various dietary modifications including frequent low fat meals. However, if dietary modifications alone are unsuccessful, antiemetic and prokinetic drugs, or combinations thereof, are generally tried. If symptoms cannot be controlled with medication, supplemental nutrition via enteral or parenteral feeding may be required to maintain hydration and nutritional status. Prokinetic drugs are intended to promote gastric motility, i.e., to return abnormally slow gastric emptying states to normal. Antiemetic drugs are intended to alleviate symptoms of nausea and vomiting, but have no effect on motility. None of the prokinetic drugs are labeled for improved gastric emptying in gastroparesis. Metoclopramide is the only antiemetic or prokinetic drug indicated for use in the treatment of symptoms of diabetic gastroparesis.
Surgical procedures are occasionally employed to manage symptoms of gastroparesis while maintaining the ability for enteral feeding. Surgical procedures, including gastrectomy, pyloroplasty, and gastrojejunostomy, have had limited success in managing symptoms of gastroparesis. When drug therapies or surgery are ineffective, supplemental enteral feeding via gastric or jejunal feeding tubes or total parenteral nutrition (TPN) may be required to meet the patient's nutritional needs.
For those patients who cannot be adequately treated or managed by current medical practice, the GES has no satisfactory alternative. It is this group of patients for which the GES System is indicated.
- Conditions
- Gastroparesis
- Being tested
- Enterra Therapy Gastric Stimulator
- Keywords
- Enterra therapy, Gastric Simulation System
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enterra Therapy Gastric StimulatorDevice
The intramuscular stomach leads, implanted in a minimally invasive surgical procedure lasting 1-3 hours, are placed on the greater curvature of the stomach. The implanted pulse generator (IPG) is about 2 1/2" x 2" x 1/2" and is implanted in a subcutaneous pocket, generally created in the abdominal area, and is then connected to the leads. The IPG provides the energy source that delivers the electrical pulse to the stomach muscle through the stomach leads to improve the symptoms of gastroparesis.
The doctor will use an external programmer to change the settings of the neurostimulator and control the neurostimulator after implantation. Part of the programmer is held outside the body over the implant site and can adjust or change the settings of the neurostimulator using radio remote control.
| Study group | Role | What they receive |
|---|---|---|
| Enterra Therapy | Experimental | The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted. Receives: Device: Enterra Therapy Gastric Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Episodes of Nausea and Vomiting
Data was not analyzed because PI left institution and terminated the study early.
Measured: 1 year
Secondary outcomes (1)
Number of Episodes of Abdominal Pain, Bloating, and Early Satiety
Data was not analyzed because PI left institution and terminated the study early.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startOct 2004
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: Principal investigator left institution.
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 GastroparesisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dennis L. Fowler, M.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556166
- Sponsor's protocol ID
- AAAA5072
- Acronym
- Enterra
- Status last verified
- Jun 2016
- First submitted
- 8 Nov 2007
- Last updated
- 2 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: No data available to share as the PI left the institution before the study could finish.
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enterra Therapy Gastric Stimulation System
- ClinicalTrials.gov ID
- NCT00556166
- Acronym / sponsor ID
- Enterra / AAAA5072
- Conditions
- Gastroparesis
- Keywords
- Enterra therapy, Gastric Simulation System
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal investigator left institution.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 9 Nov 2007 (estimated)
- Results
- Posted 2 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Enterra Therapy Gastric Simulation System (Enterra Therapy) is indicated for the treatment of patients with long term, uncontrolled (not helped by medication) nausea and vomiting from gastroparesis of diabetic or idiopathic origin.
In March 2000, the Food and Drug Administration (FDA) gave approval of a humanitarian Device Exemption (HDE) of a Humanitarian Use Device (HUD) for Enterra Therapy Gastric electrical (GES) Simulation System. Although, there is evidence that suggests the use of Enterra Therapy System probably helps patients, symptoms, the FDA's HDE approval indicates that the helpfulness of this therapy has not been proven. Physicians at Columbia University Medical Center hope to prove the helpfulness of this device.
Detailed description
Gastroparesis is a debilitating disease in which patients suffer from a number of upper gastrointestinal (GI) symptoms including nausea, vomiting, early satiety, bloating, postprandial fullness, epigastric pain and burning, and cardiac pain and burning. Severe symptoms, particularly vomiting and nausea, can significantly impair a patients daily activities and quality of life.
Current medical practice for the treatment and/or management of gastroparesis consists of dietary modifications, drug therapies, enteral feeding, parenteral feeding and surgery. These treatments are successful for some patients, but have significant drawbacks. Patients may initially be treated with various dietary modifications including frequent low fat meals. However, if dietary modifications alone are unsuccessful, antiemetic and prokinetic drugs, or combinations thereof, are generally tried. If symptoms cannot be controlled with medication, supplemental nutrition via enteral or parenteral feeding may be required to maintain hydration and nutritional status. Prokinetic drugs are intended to promote gastric motility, i.e., to return abnormally slow gastric emptying states to normal. Antiemetic drugs are intended to alleviate symptoms of nausea and vomiting, but have no effect on motility. None of the prokinetic drugs are labeled for improved gastric emptying in gastroparesis. Metoclopramide is the only antiemetic or prokinetic drug indicated for use in the treatment of symptoms of diabetic gastroparesis.
Surgical procedures are occasionally employed to manage symptoms of gastroparesis while maintaining the ability for enteral feeding. Surgical procedures, including gastrectomy, pyloroplasty, and gastrojejunostomy, have had limited success in managing symptoms of gastroparesis. When drug therapies or surgery are ineffective, supplemental enteral feeding via gastric or jejunal feeding tubes or total parenteral nutrition (TPN) may be required to meet the patient's nutritional needs.
For those patients who cannot be adequately treated or managed by current medical practice, the GES has no satisfactory alternative. It is this group of patients for which the GES System is indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enterra Therapy | Experimental | Device: Enterra Therapy Gastric StimulatorThe Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic(long term, lasting greater than 3 months)
- Intractable (drug refractory, failed medical management with prokinetic and antiemetic drugs
- Failed dietary modifications, and/or requiring enteral feeding) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology
Key exclusion criteria (1 listed)
- Only patients whom the physician determines are not a candidate for surgical procedures and/or anesthesia due to physical or mental conditions will be excluded. This includes pregnant women, anyone unable to tolerate general anesthesia, and uncorrectable coagulopathy.
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 Therapy Gastric StimulatorThe intramuscular stomach leads, implanted in a minimally invasive surgical procedure lasting 1-3 hours, are placed on the greater curvature of the stomach. The implanted pulse generator (IPG) is about 2 1/2" x 2" x 1/2" and is implanted in a subcutaneous pocket, generally created in the abdominal area, and is then connected to the leads. The IPG provides the energy source that delivers the electrical pulse to the stomach muscle through the stomach leads to improve the symptoms of gastroparesis. The doctor will use an external programmer to change the settings of the neurostimulator and control the neurostimulator after implantation. Part of the programmer is held outside the body over the implant site and can adjust or change the settings of the neurostimulator using radio remote control. | Device | Enterra Therapy |
Primary outcome
Number of Episodes of Nausea and Vomiting
Time frame: 1 year
Data was not analyzed because PI left institution and terminated the study early.
1 secondary outcome
Number of Episodes of Abdominal Pain, Bloating, and Early Satiety
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No data available to share as the PI left the institution before the study could finish.
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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.
Dennis L. Fowler, M.D. principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enterra Therapy Gastric Stimulator in people with Gastroparesis, run by Columbia University 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 1 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 2 Aug 2016. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 2 Aug 2016). 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?
Number of Episodes of Nausea and Vomiting (time frame: 1 year). 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 2 Aug 2016.