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EndoFLIP + Manometry Predictors for Gastroparesis Treatment
N/A
Waitlist Available
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All patients aged 18+ diagnosed with refractory gastroparesis as defined earlier in this document, no age limit
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
Study Summary
This trial is to study if a new imaging technology can help predict which patients with a chronic stomach condition will respond to a new treatment.
Who is the study for?
This trial is for adults with refractory gastroparesis, which means their stomachs empty slowly despite diet changes or medications. They must be planning to have G-POEM surgery and not have had previous gastric surgery, be pregnant, use narcotics recently, or have serious blood disorders or other health issues that make endoscopy unsafe.Check my eligibility
What is being tested?
The study tests how well patients respond to G-POEM treatment by using two techniques: EndoFLIP measures the stomach's ability to stretch and hold food; ADM checks muscle contractions in the digestive tract. These tests aim to predict if G-POEM will help relieve symptoms of slow stomach emptying.See study design
What are the potential side effects?
Potential side effects from EndoFLIP and ADM are usually minor but can include discomfort at the procedure site, nausea during testing, and rarely more serious complications like bleeding or perforation due to the insertion of instruments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older with gastroparesis that hasn’t improved with treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Predictive Value of ADM
Predictive Value of EndoFLIP
Secondary outcome measures
EndoFLIP data correlation
Gastric-Emptying Characteristics
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Addition of ADM and EndoFLIP to pre-G-POEM evaluationExperimental Treatment2 Interventions
During the preoperative upper endoscopy, the EndoFLIP catheter is inserted through the mouth with endoscopic guidance and placed through the gastric pylorus. Once deployed, water is sequentially added at set volumes to a balloon that can be used to measure pyloric diameter, cross-sectional area, pressure, and distensibility at set volumes of 30, 40, and 50 mL for at least five seconds. We will record this data for each patient. The EndoFLIP catheter will then be removed. Subsequently, a high resolution ADM catheter will be inserted through the nose and placed through the pylorus to measure baseline intragastric, transpyloric, and intraduodenal pressures. The patient will be observed for up to four hours to assess a migrating motor complex (MMC). After the MMC is observed, the patient will be given a meal and observed for meal response with the manometry catheter. The meal will be water and two pieces of toast/bread. Following the meal, the catheter will be removed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EndoFLIP
2017
N/A
~50
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,230 Total Patients Enrolled
1 Trials studying Gastroparesis
36 Patients Enrolled for Gastroparesis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not healthy enough for a standard endoscopy procedure.I have used narcotics within the last four weeks.You have already agreed to have a G-POEM procedure.I am 18 or older with gastroparesis that hasn’t improved with treatment.The study team thinks you might not live for more than a year because of other health problems.I have had surgery on my stomach in the past.I am not pregnant, as confirmed by a urine test.Your blood doesn't clot normally and it can't be fixed.My platelet count is below 50,000 and cannot be increased with treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Addition of ADM and EndoFLIP to pre-G-POEM evaluation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Gastroparesis Patient Testimony for trial: Trial Name: NCT04844190 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is enrollment for this study open to participants?
"Affirmative, the details on clinicaltrials.gov demonstrate that this investigation is at present recruiting participants. The inquiry was initially posted on April 15th 2021 and recently amended on April 13th 2021. This research requires 20 people to be enrolled from a single site."
Answered by AI
Are there any openings for enrollment in this research endeavor?
"Affirmative. According to records hosted on clinicaltrials.gov, this medical investigation is recruiting at the present moment; it was first published April 15th 2021 and last updated a few days ago on April 13th 2021. At one site, 20 research volunteers need to be enrolled into the trial."
Answered by AI
Who else is applying?
What state do they live in?
California
Illinois
Mississippi
Other
How old are they?
18 - 65
What site did they apply to?
Northwestern Memorial Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
2
Why did patients apply to this trial?
Nothing I have tried works. I’ve tried many other medical interventions and I’m still having severe symptoms.
PatientReceived 2+ prior treatments
I've tried everything for Gastroparesis and I'm desperate to find something that works for me.
PatientReceived 2+ prior treatments
I’ve been on zero medications I have a gastric stimulator. My bowels are severely affected. Due to long term serious food issues it makes it impossible for me to follow a gastroparesis diet.
PatientReceived 2+ prior treatments
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