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Procedure
G-POEM for Gastroparesis
N/A
Recruiting
Led By Pankaj Pasricha, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Symptoms of chronic nausea or vomiting compatible with gastroparesis (idiopathic or diabetic) must be present for at least one year (does not have to be contiguous) prior to registration with mean total Gastroparesis Cardinal Symptom Index (GCSI) score of ≥ 2.3
Symptoms of chronic nausea or vomiting compatible with gastroparesis (idiopathic or diabetic) must be present for at least one year (does not have to be contiguous) prior to registration.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 48 weeks post treatment
Awards & highlights
Study Summary
This trial will compare the effects of a new treatment, gastric peroral endoscopic myotomy (G-POEM), to a sham surgery, for patients with gastroparesis.
Who is the study for?
This trial is for adults with gastroparesis, a condition causing chronic nausea or vomiting, who haven't improved after trying standard treatments for at least six months. Participants must have confirmed delayed gastric emptying and a specific symptom severity score. Excluded are those with other conditions that could explain symptoms, severe systemic illnesses, uncontrolled diabetes, recent changes in medications for gastroparesis, pregnancy, or certain allergies.Check my eligibility
What is being tested?
The study compares the effectiveness of G-POEM (a surgical procedure to cut stomach muscles) against sham surgery (a fake operation) over 12 months in patients whose gastroparesis doesn't respond to medication. The goal is to see which treatment helps more and identify factors predicting better outcomes.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include pain at the incision site from the endoscopic procedure, infection risk due to surgery, gastrointestinal symptoms like bloating or diarrhea post-procedure and possible anesthesia-related complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had symptoms like chronic nausea or vomiting for at least a year.
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I have had symptoms like chronic nausea or vomiting for at least a year.
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My severe stomach emptying issue hasn't improved despite trying many treatments.
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My upper GI tests show no blockages.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 48 weeks post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 48 weeks post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
GCSI-DD change
Secondary outcome measures
Change in Quality of Life as assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life scale
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: G-POEMExperimental Treatment1 Intervention
Group II: Sham procedurePlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,209 Previous Clinical Trials
3,767,104 Total Patients Enrolled
9 Trials studying Gastroparesis
597 Patients Enrolled for Gastroparesis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,315,465 Total Patients Enrolled
19 Trials studying Gastroparesis
3,389 Patients Enrolled for Gastroparesis
Johns Hopkins UniversityOTHER
2,262 Previous Clinical Trials
14,823,134 Total Patients Enrolled
11 Trials studying Gastroparesis
1,198 Patients Enrolled for Gastroparesis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My stomach empties slowly, with tests showing more than 25% of food remains after 4 hours.I am currently taking medication that affects stomach emptying or mood stabilizers.My severe stomach emptying issue hasn't improved despite trying many treatments.You are allergic to eggs or egg-based products like Egg Beaters and Ensure.I have had symptoms like chronic nausea or vomiting for at least a year.I have not had a Botox injection in my pylorus in the last 3 months.My stomach empties slowly, confirmed by a test within the last 18 months.I have had symptoms like chronic nausea or vomiting for at least a year.You have another health condition that could be causing your symptoms according to the doctor.Your stomach empties solids too slowly after eating.I do not have severe kidney or liver disease.My diabetes is not well-managed, with an HbA1c over 10%.I started new medication for gastroparesis symptoms less than a month ago.I have had symptoms like chronic nausea or vomiting for at least a year.You must have a total Gastroparesis Cardinal Symptom Index (GCSI) score of 3 or higher during the screening visit.My upper GI tests show no blockages.
Research Study Groups:
This trial has the following groups:- Group 1: G-POEM
- Group 2: Sham procedure
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment in this trial still a possibility for prospective participants?
"As the information on clinicaltrials.gov indicates, this medical trial is no longer actively recruiting patients; although it was first posted on January 15th 2023 and updated lastly in July 12th 2022. Fortunately, there are currently 29 other studies that require participation right now."
Answered by AI
What are the eligibility requirements for participation in this clinical exploration?
"The criteria for participating in this medical understanding necessitates that the individual has gastroparesis and is aged between 18 and 70. The research team seeks to recruit 45 people."
Answered by AI
Does this trial include participants of 45 years or older?
"The requirements for enrollment in this trial dictate that candidates must between 18 and 70 years of age. For all other ages, there are 4 trials available to those under 18 while 27 exist specifically designed for elderly patients over the age 65."
Answered by AI
Who else is applying?
What state do they live in?
California
Florida
How old are they?
18 - 65
What site did they apply to?
Johns Hopkins Bayview Medical Center
Mayo Clinic Arizona
Mayo Clinic
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I need this surgery and insurance keeps denying it. I've tried multiple medium and botox injections with little to no relief.
PatientReceived no prior treatments
I’ve tried the Botox to the pylorus, worked great! Trying to get the gpoem, insurance keeps denying it.
PatientReceived 2+ prior treatments
Trying to improve Gastropsresis symptoms. Nothing has worked, and I have tried every medication, diet, etc.
PatientReceived no prior treatments
I have been suffering from GP for 2 years and have discussed a GPOEM with Gastroenterologist as a potential solution as prescription medications are not an option.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
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