Endoluminal Therapy

Endoscopic Therapy for Esophageal Achalasia

Sacramento, CA

N/A

Waitlist Available

Led By Mohamed R Ali, MD

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

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

Must have

Achalasia

Barrett's Esophagus

Must not have

Adults unable to consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing different ways to treat digestive conditions using endoluminal therapies, which are procedures that go through the GI tract from the inside.

Who is the study for?

This trial is for adults aged 18-80 with various upper and lower GI conditions, including Achalasia, Barrett's Esophagus, GERD, and complications from bariatric surgery. Candidates must qualify for gastrointestinal surgeries of benign or malignant nature. Those unable to consent or not meeting the criteria for endoluminal treatments are excluded.

What is being tested?

The study is evaluating the outcomes of different endoscopic interventions on patients with a range of GI disorders such as Esophageal Achalasia and complications post-bariatric surgery like fistulas and ulcers.

What are the potential side effects?

While specific side effects are not listed here, endoscopic interventions may generally include risks such as sore throat, infection risk at the intervention site, bleeding, perforation of the GI tract, adverse reactions to sedatives used during procedures.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with achalasia.

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I have Barrett's Esophagus.

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I have had bariatric surgery.

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I am eligible for surgery to treat my gastrointestinal condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to give consent for medical procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-6 months

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Decrease in GERDDQ

Secondary study objectives

Decrease in Eckardt scoring

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Patients meeting inclusion criteria for possible surgical therapies for their current condition (IE Achelasia, Enlarged Gastric Pouch and/or Gastrogastric Fistula after primary weight loss surgery, etc) will be educated on the different therapy options including traditional laparoscopic surgery and/or Endoscopic Interventions including POEM (Percutaneous Oral Endoscopic Myomectomy for the treatment of Achelasia) or Endoscoscopic Pouch/GastroJejunostomy repair or closure of the Gastrogastric Fistula as examples.

0 / 5Eligibility criteria met