Minimally Invasive Surgery of the Gastro-esophageal Junction | NCT01799967

Studies
Minimally Invasive Surgery of the Gastro-esophageal Junction

NCT01799967

Sponsor

Ottawa Hospital Research Institute

Status

Active, not recruiting

Last Update Posted

Jan 30, 2026Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Achalasia
Paraesophageal Hernia
GERD
Epiphrenic Diverticula
Zenker's Diverticulum

Interventions

Not provided

Countries

Canada

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

Dec 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Nov 2027Estimated

Completion Date

Nov 2027Estimated

First Submitted Date

Feb 25, 2013

First Submission Date that Met QC Criteria

Feb 26, 2013

First Posted Date

Feb 27, 2013Estimated

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

Jan 28, 2026

Last Update Posted Date

Jan 30, 2026Actual

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 study will assess short and long term outcomes of individuals undergoing minimally invasive surgery of the gastro-esophageal junction (MISGEJ). Patients will respond to questionnaires on an annual basis evaluating quality of life and functionality following MISGEJ. Hospital charts will also be reviewed on an annual basis to assess patient health outcomes.

Detailed Description

Not provided

Conditions Module

Conditions

Achalasia
Paraesophageal Hernia
GERD
Epiphrenic Diverticula
Zenker's Diverticulum

Keywords

gastro-esophageal junction
minimally invasive
Achalasia
Paraesophageal hernia
GERD
Epiphrenic diverticula
Zenker's diverticulum
All minimally invasive surgeries of the gastro-esophageal junction

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MISGEJ symptoms (subjective)	MISGEJ symptom questionnaire evaluated on an annual basis	8 years
Achalasia Disease Severity (subjective)	Achalasia Disease Severity questionnaire evaluated on an annual basis.	8 years
Diagnostic imaging	Patient x-rays, upper GI tests, Endoscopy, and/or CT scans will be assessed on an annual basis to objectively measure functionality and health status.	8 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients at the Ottawa Hospital undergoing minimally invasive surgery of the GEJ

Exclusion Criteria:

Less than 18 years of age.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients undergoing minimally invasive surgery of the gastro-esophageal junction at the Ottawa Hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrew JE Seely, MD, PhD	Ottawa Hospital Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ottawa Hospital Research Institute		Ottawa	Ontario	K1H8L6	Canada

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004931	Esophageal Achalasia
D006551	Hernia, Hiatal
D005764	Gastroesophageal Reflux
D016672	Zenker Diverticulum

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided