GastroparesisTempGESNCT02164591
Escalating Temporary Gastric Electrical Stimulation (GES) for Severe Gastroparesis
An observational study of Gastroparesis, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to determine the physiologic effects of temporary gastric electrical stimulation in subjects with severe gastroparesis. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastroparesis
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have been diagnosed with gatroparesis.
Who may be able to join
- At least 3 months of gastroparesis-related symptoms, such as nausea, emesis, and/or retching
- Solid phase 4-hr gastric scintigraphy is consistent with gastroparesis within 3 months of study enrollment*
- retention at 2 hr: >60% or
- retention at 4 hr: >10% *Based on International consensus on gastric scintigraphy
Who cannot join
- Gastric outlet, small bowel, or colon obstruction.
- Small bowel malrotation
- Inflammatory bowel disease
- Contraindication for surgical implantation of GES
- Presence of illness that may require MRI during the study; such as pituitary tumor, herniated disc, spinal stenosis, multiple sclerosis, etc.
- Significant comorbidity due to sever cardiovascular, renal, pulmonary, or liver disease.
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- Significant coagulopathy
- Non-ambulatory patients: bed-ridden, nursing home resident, etc.
- Pregnancy
- Unable to give own informed consent
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Hosptial
Indianapolis, Indiana, 46202
About this study
Official title: Escalating Temporary Gastric Electrical Stimulation for Severe Gastroparesis
The purpose of this study is to determine the physiologic effects of temporary gastric electrical stimulation in subjects with severe gastroparesis.
Read the detailed description
This study will look to determine the clinical benefit placing temporary gastric electrical stimulation, the ability to predict the clinical response to surgical implantation of GES, and the feasibility and patient tolerability of endoscopic placement of temporary Gastric Electrical Stimulator (t-GES),
- Conditions
- Gastroparesis
- Keywords
- gastroparesis, gastric electrical stimulator, GES, vomiting, nausea, bloating, postprandial fullness, epigastric pain
- Medical subject headings
- Gastroparesis, Vomiting, Nausea
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in the symptoms of gastroparesis by t-GES in patients with severe gastroparesis.
Review the symptoms before and after the t-GES placements and follow for any improvement
Measured: 1 month
Secondary outcomes (3)
Clinical response to t-GES placement as measured by questionnaires
Measuring the responses to questionnaires before and after placement of GES
Measured: 1 year
Develop a prospective registry in patients undergoing escalating t-GES
Have a database of patients undergoing t-GES placement
Measured: 1 year
determine the feasibility and patient tolerability of endoscopic placement of t-GES
Determine if placement of t-GES is feasible and if the patients tolerate the t-GES
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 posted16 Jun 2014 (estimated)
- Study startFeb 2013
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John M. Wo, Indiana University
- Investigators
- John M Wo, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164591
- Sponsor's protocol ID
- Temp GES
- Acronym
- TempGES
- Status last verified
- Aug 2020
- First submitted
- 6 Jun 2014
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Escalating Temporary Gastric Electrical Stimulation for Severe Gastroparesis
- ClinicalTrials.gov ID
- NCT02164591
- Acronym / sponsor ID
- TempGES / Temp GES
- Conditions
- Gastroparesis
- Keywords
- gastroparesis, gastric electrical stimulator, GES, vomiting, nausea, bloating, postprandial fullness, epigastric pain
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 16 Jun 2014 (estimated)
- Results
- Not posted in the source record
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 study is to determine the physiologic effects of temporary gastric electrical stimulation in subjects with severe gastroparesis.
Detailed description
This study will look to determine the clinical benefit placing temporary gastric electrical stimulation, the ability to predict the clinical response to surgical implantation of GES, and the feasibility and patient tolerability of endoscopic placement of temporary Gastric Electrical Stimulator (t-GES),
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have been diagnosed with gatroparesis.
Key inclusion criteria (4 listed)
- At least 3 months of gastroparesis-related symptoms, such as nausea, emesis, and/or retching
- Solid phase 4-hr gastric scintigraphy is consistent with gastroparesis within 3 months of study enrollment*
Key exclusion criteria (11 listed)
- Gastric outlet, small bowel, or colon obstruction.
- Small bowel malrotation
- Inflammatory bowel disease
- Contraindication for surgical implantation of GES
- Presence of illness that may require MRI during the study; such as pituitary tumor, herniated disc, spinal stenosis, multiple sclerosis, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Improvement in the symptoms of gastroparesis by t-GES in patients with severe gastroparesis.
Time frame: 1 month
Review the symptoms before and after the t-GES placements and follow for any improvement
3 secondary outcomes
Clinical response to t-GES placement as measured by questionnaires
Time frame: 1 year
Develop a prospective registry in patients undergoing escalating t-GES
Time frame: 1 year
determine the feasibility and patient tolerability of endoscopic placement of t-GES
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
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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.
John M Wo, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroparesis, run by Indiana 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 4 inclusion and 11 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 4 Aug 2020. 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?
The study was stopped early. Results are not available in the source record.
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?
Improvement in the symptoms of gastroparesis by t-GES in patients with severe gastroparesis. (time frame: 1 month). 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 4 Aug 2020.