BridgeMD
New treatment option for Type I Achalasia
Official title PREcision MEDicine In Achalasia (PREMEDIA)
ClinicalTrials.gov ID: NCT07293650
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn if shorter Per-Oral Endoscopic Myotomy (POEM) works as well as a longer POEM in patients with trouble swallowing due to certain conditions. The main question(s) it aims to answer [is/are]: Does making a smaller cut in the muscle at the bottom of the esophagus work just as well as making the standard bigger cut in relieving symptoms?
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18
- Type I achalasia or type II achalasia or cEGJOO
- Eckardt score \> 3
You likely can't join if
- The following exclusion criteria are for the RCT, but 1-13 below also pertain to the observational study:
- Prior POEM
- Prior surgical treatment for achalasia
- Endoscopic pneumatic dilation or lower esophageal sphincter botulinum toxin (botox) injection within 6 months
- Prior unrelated esophageal or upper gastric surgery, including Roux-en-Y gastric bypass and sleeve gastrectomy
- Prior endoscopic gastroesophageal intervention for obesity or GERD, such endoscopic sleeve gastroplasty or transoral incisionless fundoplication
See the full eligibility criteria
- Age ≥ 18
- Type I achalasia or type II achalasia or cEGJOO
- Eckardt score \> 3
- The following exclusion criteria are for the RCT, but 1-13 below also pertain to the observational study:
- Prior POEM
- Prior surgical treatment for achalasia
- Endoscopic pneumatic dilation or lower esophageal sphincter botulinum toxin (botox) injection within 6 months
- Prior unrelated esophageal or upper gastric surgery, including Roux-en-Y gastric bypass and sleeve gastrectomy
- Prior endoscopic gastroesophageal intervention for obesity or GERD, such endoscopic sleeve gastroplasty or transoral incisionless fundoplication
- Known secondary achalasia related to malignancy (pseudoachalasia)
- Known eosinophilic esophagitis
- Diverticulum (\> 2 cm) in distal esophagus
- Megaesophagus
- Fibroinflammatory stricture of the esophagus due to any etiology (e.g., peptic, radiation, eosinophilic)
- Pregnancy
- Standard contraindications to general anesthesia
- Standard contraindications to endoscopic myotomy in the esophagus (e.g. untreated varices)
- Unwillingness or inability to consent for the study
- Anticipated inability to follow protocol
- Weekly (or more frequent) opioid medication use in the last 2 years
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- La Jolla, California, United States
- Denver, Colorado, United States
- Gainesville, Florida, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; La Jolla, California, United States; Denver, Colorado, United States; Gainesville, Florida, United States; Orlando, Florida, United States; Atlanta, Georgia, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.