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Procedure

POP Surgery for Gastroparesis in Diabetes

N/A

Recruiting

Led By Mathew Allemang, MD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with gastroparesis with an average HbA1c> 7.5% over the past 3 months

Patient that have a diagnosis of gastroparesis established by documented delayed gastric emptying by either a wireless motility capsule study or a nuclear gastric emptying study, with no evidence of gastric obstruction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 6 month

Awards & highlights

Study Summary

This trial will test a new surgery to help manage diabetes in 40 patients who have a stomach condition that has not gotten better with other treatments.

Who is the study for?

This trial is for adults over 18 with diabetes and gastroparesis, confirmed by specific stomach emptying tests. They must have struggled to control their blood sugar levels, with an average HbA1c above 7.5% in the past three months, and be willing to follow all study procedures.Check my eligibility

What is being tested?

The trial is testing whether a procedure called per-oral pyloromyotomy (POP), which involves cutting muscles at the stomach's exit to ease food passage, can improve blood sugar control in patients with difficult-to-treat gastroparesis.See study design

What are the potential side effects?

Potential side effects of POP may include discomfort or pain at the procedure site, infection risk, bleeding complications, and possibly changes in digestion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My average blood sugar level has been high over the past 3 months.

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I have been diagnosed with gastroparesis confirmed by a special stomach emptying test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 6 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 6 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline in Glucose Levels measured by Continuous Glucose Monitor

Change from Baseline in Hemoglobin A1C levels

Secondary outcome measures

Change from Baseline on Diabetes Self-Management Questionnaire

Change from Baseline on Gastroparesis Cardinal Symptom Index

Trial Design

1Treatment groups

Experimental Treatment

Group I: Endoscopic Per-Oral Pyloromyotomy (POP)Experimental Treatment1 Intervention

The study cohort will include 40 patients with a HbA1c >7.5% with medically refractory gastroparesis who are scheduled to undergo POP. Each patient will undergo two 10-day periods of CGM at an interval of approximately seven months, one month prior to the procedure and six months after. Symptoms and diabetes management improvement will be measured by the Gastroparesis Cardinal Symptom Index (GCSI) scores and the Diabetes Self-Management Questionnaire (DSMQ).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,029 Previous Clinical Trials

1,365,038 Total Patients Enrolled

1 Trials studying Gastroparesis

100 Patients Enrolled for Gastroparesis

Matthew AllemangLead Sponsor

1 Previous Clinical Trials

100 Total Patients Enrolled

1 Trials studying Gastroparesis

100 Patients Enrolled for Gastroparesis

Society of American Gastrointestinal and Endoscopic SurgeonsOTHER

9 Previous Clinical Trials

622 Total Patients Enrolled

Media Library

Gastroparesis Research Study Groups: Endoscopic Per-Oral Pyloromyotomy (POP)

Gastroparesis Clinical Trial 2023: Per-oral Pyloromyotomy (POP) Highlights & Side Effects. Trial Name: NCT04696159 — N/A

Per-oral Pyloromyotomy (POP) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04696159 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the trial still recruiting participants?

"As detailed on clinicaltrials.gov, this research is not recruiting patients at the present time. Initially posted in December 1st 2022, and most recently amended August 1st 2022, this study is no longer taking partcipants; however there are 1196 other trials that still require volunteers right now."

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