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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with diabetic, idiopathic or post-surgical gastroparesis
Patients with confirmed diagnosis of gastroparesis via gastric emptying study (abnormal gastric emptying will be defined as ≥10 % residual activity at 4 h on a standardized nuclear medicine TC-99 m sulfur colloid solid-phase gastric emptying study)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-2 years
Awards & highlights
Study Summary
This trial will test whether a metal stent placed across the pylorus predicts success of a later endoscopic pyloromyotomy for patients with refractory gastroparesis.
Who is the study for?
This trial is for adults over 18 with gastroparesis that hasn't improved with standard treatments or those who can't take them due to allergies. It's open to patients with diabetic, idiopathic, or post-surgical forms of the condition confirmed by a gastric emptying study. People can't join if they've had certain GI surgeries, cancer in the stomach area, are unstable for endoscopy procedures, have liver cirrhosis, are pregnant/breastfeeding, or have significant blood clotting issues.Check my eligibility
What is being tested?
The study is testing whether placing a transpyloric stent (a type of tube) across the pylorus (the stomach's exit) predicts success for a later procedure called G-POEM in treating severe gastroparesis. Participants will be randomly assigned to receive either the actual stenting procedure or a sham (fake) procedure as part of this forward-looking research.See study design
What are the potential side effects?
Potential side effects from transpyloric stenting may include discomfort at the stent site, risk of infection, bleeding during placement and possible migration or blockage caused by the stent. The severity and occurrence can vary among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have gastroparesis due to diabetes, surgery, or an unknown cause.
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I have been diagnosed with gastroparesis through a gastric emptying study.
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I am over 18 with gastroparesis not improved by standard treatments or cannot use them due to allergies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical response will be assessed by the gastroparesis cardinal symptom index (GCSI) scores
Secondary outcome measures
Adverse events
Age
BMI
+3 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Transpyloric stentActive Control1 Intervention
In this group, patient's will be randomized to receive a transpyloric stent for treatment of refractory gastroparesis. They will be blinded for one month after stent placement as to whether they received a stent or sham.
Group II: ShamPlacebo Group1 Intervention
In this group, patient's will be randomized to sham for treatment of refractory gastroparesis. They will be blinded for one month after stent placement as to whether they received a stent or sham.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for gastroparesis include pharmacologic agents like metoclopramide, which enhances gastric motility by stimulating muscle contractions in the stomach, and erythromycin, which mimics the action of motilin to promote gastric emptying. Endoscopic and surgical interventions, such as gastric per-oral endoscopic pyloromyotomy (G-POEM) and transpyloric stenting with lumen apposing metal stent (LAMS), aim to improve gastric emptying by addressing pyloric dysfunction.
These procedures keep the pylorus open, allowing for better passage of stomach contents into the small intestine. This is crucial for gastroparesis patients as it helps alleviate symptoms like nausea, vomiting, and abdominal pain, thereby improving their quality of life.
A Systematic Review of the Therapeutic Role of Gastric Pacemakers in Adults With Gastroparesis.
A Systematic Review of the Therapeutic Role of Gastric Pacemakers in Adults With Gastroparesis.
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,601 Previous Clinical Trials
915,623 Total Patients Enrolled
1 Trials studying Gastroparesis
1 Patients Enrolled for Gastroparesis
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