Per-Oral Endoscopic Myotomy | NCT01402518

Studies
Per-Oral Endoscopic Myotomy

NCT01402518

Sponsor

University of California, San Diego

Status

Completed

Last Update Posted

Mar 10, 2020Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Achalasia

Interventions

Per-oral enodscopic myotomy

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

Apr 2018

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

Nov 2009

Primary Completion Date

Nov 2019Actual

Completion Date

Nov 2019Actual

First Submitted Date

Jul 21, 2011

First Submission Date that Met QC Criteria

Jul 25, 2011

First Posted Date

Jul 26, 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

Mar 8, 2020

Last Update Posted Date

Mar 10, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Santiago Horgan, Professor of Surgery, University of California, San DiegoPrincipal Investigator

Lead Sponsor

University of California, San DiegoOTHER

Collaborators

Not provided

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 prospective chart review/data collection study of the per oral endoscopic myotomy (POEM) procedure, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a POEM procedure. Data will be collected and reviewed through 12 months post-op.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Per-oral endoscopic myotomy			Procedure: Per-oral enodscopic myotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Per-oral enodscopic myotomy	Procedure		Per-oral endoscopic myotomy	POEM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the outcomes of the per-oral endoscopic myotomy (POEM) procedure for the treatment of achalasia		1 year

Secondary Outcomes

Measure	Description	Time Frame
To assess the quality of life, pain, and complications of the POEM approach		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion:

Diagnosis of achalasia
Age 18-75
Mentally competent to give informed consent
Scheduled to undergo a POEM procedure

Exclusion:

Pregnant women
Any prior surgical treatment for achalasia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients between the ages of 18-75 who present in the UC San Diego Surgical Specialties clinic with the diagnosis of achalasia will be offered participation in this study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Santiago Horgan, M.D., FACS	UCSD	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Diego		San Diego	California	92103	United States

Condition Browse Module

MeSH Terms

ID	Term
D004931	Esophageal Achalasia
D003680	Deglutition Disorders

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided