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Endolumenal Partial Myotomy for Esophageal Motility Disorders

Endoscopic Submucosal Tunnel Dissection for Endolumenal Partial Myotomy of the Lower Esophageal Sphincter for Atypical Primary Motility Disorders Such as Achalasia and Esophageal Spasm

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01302301
Enrollment
20
Registered
2011-02-24
Start date
2011-01-31
Completion date
Unknown
Last updated
2011-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Motility Disorders

Keywords

endolumenal myotomy, per oral endoscopic myotomy

Brief summary

Achalasia and esophageal spasm are primary esophageal motility disorders where the lower esophageal sphincter fails to relax in response to swallowing with no well understood underlying cause. Surgical myotomy represents an appropriate therapeutic option. The purpose of this study is to evaluate flexible endoscopic myotomy a novel therapeutic approach to overcome the need for invasive surgery.

Detailed description

In this study, the investigators propose the use of a recent endolumenal technique for partial myotomy in patients suffering from primary esophageal motility disorders. Under general anesthesia patients will have upper endoscopy. Submucosal injection and mucosal incision is created for entry into the submucosal space. A submucosal tunnel is then created using a needle knife or blunt dissection as appropriate. Dissection will continue distally beyond the lower esophageal sphincter. The inner circular muscle fibers will then be divided to achieve an adequate myotomy length. The mucosal entry is then closed appropriately. Results will be compared to historical data of conventional Heller myotomies.

Interventions

flexible endoscopic submucosal esophageal partial myotomy

Sponsors

The Oregon Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Candidate for elective Heller myotomy * Ability to undergo general anesthesia * Ability to give informed consent

Exclusion criteria

* Previous mediastinal or esophageal surgery * Contraindications for EGD

Design outcomes

Primary

MeasureTime frameDescription
Esophageal Function Tests6 monthupper endoscopy, barium swallow, esophageal manometry,ph Test

Secondary

MeasureTime frameDescription
Quality of life score6 monthsquality of life questionaire

Countries

United States

Contacts

Primary ContactLee L Swanstrom, MD
lswanstrom@aol.com503 281 0561

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026