AchalasiaMISGEJNCT01799967
Minimally Invasive Surgery of the Gastro-esophageal Junction
An observational study of Achalasia and Paraesophageal Hernia, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achalasia, Paraesophageal Hernia, GERD
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2007to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing minimally invasive surgery of the gastro-esophageal junction at the Ottawa Hospital.
Who may be able to join
- All patients at the Ottawa Hospital undergoing minimally invasive surgery of the GEJ
Who cannot join
- Less than 18 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Assessment Following Minimally Invasive Surgery of the Gastro-Esophageal Junction
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.
- Keywords
- gastro-esophageal junction, minimally invasive, Achalasia, Paraesophageal hernia, GERD, Epiphrenic diverticula, Zenker's diverticulum, All minimally invasive surgeries of the gastro-esophageal junction
- Medical subject headings
- Esophageal Achalasia, Hernia, Hiatal, Gastroesophageal Reflux, Zenker Diverticulum
What is being measured
The primary outcome is the main question the study is designed to answer.
MISGEJ symptoms (subjective)
MISGEJ symptom questionnaire evaluated on an annual basis
Measured: 8 years
Achalasia Disease Severity (subjective)
Achalasia Disease Severity questionnaire evaluated on an annual basis.
Measured: 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.
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startNov 2007
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew JE Seely, MD, PhD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799967
- Sponsor's protocol ID
- 2007173-01H
- Acronym
- MISGEJ
- Status last verified
- Dec 2024
- First submitted
- 25 Feb 2013
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Assessment Following Minimally Invasive Surgery of the Gastro-Esophageal Junction
- ClinicalTrials.gov ID
- NCT01799967
- Acronym / sponsor ID
- MISGEJ / 2007173-01H
- Keywords
- gastro-esophageal junction, minimally invasive, Achalasia, Paraesophageal hernia, GERD, Epiphrenic diverticula, Zenker's diverticulum, All minimally invasive surgeries of the gastro-esophageal junction
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 27 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing minimally invasive surgery of the gastro-esophageal junction at the Ottawa Hospital.
Key inclusion criteria (1 listed)
- All patients at the Ottawa Hospital undergoing minimally invasive surgery of the GEJ
Key exclusion criteria (1 listed)
- Less than 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MISGEJ symptoms (subjective)
Time frame: 8 years
MISGEJ symptom questionnaire evaluated on an annual basis
Achalasia Disease Severity (subjective)
Time frame: 8 years
Achalasia Disease Severity questionnaire evaluated on an annual basis.
Diagnostic imaging
Time frame: 8 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Achalasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew JE Seely, MD, PhD principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achalasia and Paraesophageal Hernia, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MISGEJ symptoms (subjective) (time frame: 8 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.