Endoscopic Myotomy of the Lower Esophageal Sphincter for... | NCT01399476

Studies
Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia

NCT01399476

Sponsor

The Oregon Clinic

Status

Completed

Last Update Posted

Aug 30, 2019Actual

Enrollment

350Actual

Phase

Not Applicable

Conditions

Achalasia

Interventions

Endoscopic Myotomy
Endoscopic Myotomy for treatment of achalasia

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Aug 2019Actual

Completion Date

Aug 2019Actual

First Submitted Date

Jul 19, 2011

First Submission Date that Met QC Criteria

Jul 20, 2011

First Posted Date

Jul 21, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2019

Last Update Posted Date

Aug 30, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a study of the safety and efficacy of a new surgical procedure using endoscopic instruments and a tunneling technique to reach the LES for dissection. We hypothesize that this technique provides an incisionless, less invasive option with similar functional outcome compared to standard Heller myotomy.

Detailed Description

By the endoscopic creation of an esophageal submucosal tunnel the inner circular muscle layer can be easily visualized. In contrast to conventional Heller myotomy, the dissection of only the inner circular esophageal muscle layer leaves the outer longitudinal muscle layer intact. Thereby, post-interventional reflux disease should be avoided.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

350Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endoscopic Myotomy	Experimental		Procedure: Endoscopic Myotomy Procedure: Endoscopic Myotomy for treatment of achalasia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endoscopic Myotomy	Procedure	Patients will receive the surgical procedure described in the summary (POEM).	Endoscopic Myotomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improved quality of life as defined by survey pre and post surgery	patients diagnosed with achalasia will be given a quality of life survey before surgery and again six months after surgery.	six months

Secondary Outcomes

Measure	Description	Time Frame
Negative pH test	Patients will be required to have 24 hour pH testing after surgery.	six months
Bleeding	recorded blood loss will be taken during surgery.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ability to undergo general anesthesia
Age > 18 yrs. of age and < 85 yrs. of age
Ability to give informed consent
Candidate for elective Heller myotomy

Exclusion Criteria:

Previous mediastinal or esophageal surgery
Contraindications for esophagogastroduodenoscopy
BMI > 45

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lee L Swanstrom, MD	The Oregon Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Oregon Clinic		Portland	Oregon	97210	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23394838	Derived	Kurian AA, Dunst CM, Sharata A, Bhayani NH, Reavis KM, Swanstrom LL. Peroral endoscopic esophageal myotomy: defining the learning curve. Gastrointest Endosc. 2013 May;77(5):719-25. doi: 10.1016/j.gie.2012.12.006. Epub 2013 Feb 5.

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases