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Procedure

Endoscopic Pyloromyotomy for Gastroparesis (EMPTIES Trial)

N/A

Recruiting

Led By Matthew Allemang, MD

Research Sponsored by Matthew Allemang

Eligibility Criteria Checklist

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

Must have

Male or female, aged 18-65

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline,12 weeks post-procedure

Awards & highlights

EMPTIES Trial Summary

This trial compares two different treatments for gastroparesis, a condition where the stomach can't empty properly.

Who is the study for?

This trial is for adults aged 18-75 with severe gastroparesis not improved by at least 6 months of medical treatment. Participants must be able to travel for assessments, take oral meds, follow dietary/medication regimens post-procedure, and use effective contraception if applicable. Excluded are those with post-surgical gastroparesis, pregnant or breastfeeding individuals, uncontrolled blood clotting issues, egg allergies, prior stomach surgeries or on parenteral nutrition.Check my eligibility

What is being tested?

The study compares an endoscopic procedure called per-oral pyloromyotomy (POP), which cuts the muscle at the stomach exit to improve emptying against a sham intervention without this cut in patients with tough-to-treat gastroparesis.See study design

What are the potential side effects?

Possible side effects include sore throat from the scope used during procedures; risks associated with sedation; abdominal pain; infection risk at the incision site; bleeding or perforation of the stomach lining.

EMPTIES Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 65 years old.

EMPTIES Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline,12 weeks post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline,12 weeks post-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline,12 weeks post-procedure for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Gastroparesis Cardinal Symptom Index (GCSI)

Secondary outcome measures

36-Item Short Form; Quality of Life Survey

Gastric Emptying

EMPTIES Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Endoscopic per-oral pyloromyotomy (POP)Active Control1 Intervention

Participants will undergo Endoscopic per-oral pyloromyotomy (POP).

Group II: Sham / Control ArmPlacebo Group2 Interventions

Participants will undergo a diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption. Following the 12-week blinded trial period, these participants will be unblinded and offered Endoscopic per-oral pyloromyotomy (POP) if they remain symptomatic.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Matthew AllemangLead Sponsor

1 Previous Clinical Trials

40 Total Patients Enrolled

1 Trials studying Gastroparesis

40 Patients Enrolled for Gastroparesis

The Cleveland ClinicLead Sponsor

1,027 Previous Clinical Trials

1,364,178 Total Patients Enrolled

1 Trials studying Gastroparesis

40 Patients Enrolled for Gastroparesis

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,358 Previous Clinical Trials

4,314,974 Total Patients Enrolled

19 Trials studying Gastroparesis

3,319 Patients Enrolled for Gastroparesis

Media Library

Endoscopic per-oral pyloromyotomy (POP) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05039424 — N/A

Gastroparesis Research Study Groups: Endoscopic per-oral pyloromyotomy (POP), Sham / Control Arm

Gastroparesis Clinical Trial 2023: Endoscopic per-oral pyloromyotomy (POP) Highlights & Side Effects. Trial Name: NCT05039424 — N/A

Endoscopic per-oral pyloromyotomy (POP) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05039424 — 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 minimum age requirement for this trial higher than 25 years old?

"This research is recruiting participants who are at least 18 years old but younger than 65."

Answered by AI

How many participants are currently registered for this clinical experiment?

"Aye, according to clinicaltrials.gov, this study is still open for recruitment. It was initially published on February 23rd 2022 and has been recently revised as of March 9th 2022. The trial requires 100 volunteers from one medical centre."

Answered by AI

Is there an opportunity for me to participate in this research project?

"This study aims to recruit 100 individuals suffering from gastroparesis ranging in age between 18 and 65. Qualifying participants must meet the following criteria: gender, age range, routine assessment completion, adherence to all trial procedures, ability to take oral medication as prescribed post-procedure with dietary considerations taken into account, and a reasonable expectation that they will be able travel for both physical assessments and virtual ones if necessary."

Answered by AI

Are there still open positions for participants in this research project?

"This clinical trial is currently seeking participants. First posted on February 23rd 2022, the initiative was recently updated on March 9th of this year."

Answered by AI