AchalasiaNCT03875365
Institutional Outcome Data From Per-oral Plication of the Esophagus
An observational study of Achalasia, run by Mayo Clinic at 3 sites in United States.
Trial summary
Researchers are reviewing and analyzing surgical and clinical outcomes of subjects who underwent POPE for end-stage achalasia, a sigmoid esophagus, or a redundant conduit that has been used to replace the esophagus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achalasia
- What is being tested?
- POPE
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Oct 2018to 19 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients who have already undergone Per-oral Plication of the Esophagus (POPE) procedure for end-stage achalasia, a sigmoid esophagus, or a redundant conduit that has been used to replace the esophagus.
Who may be able to join
- Adults > 18 years of age
- Patients who have already undergone Per-oral Plication of the Esophagus (POPE) procedure
Who cannot join
- Patients <18 years of age
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: Institutional Outcome Data From Per-oral Plication of the Esophagus (POPE)
Researchers are reviewing and analyzing surgical and clinical outcomes of subjects who underwent POPE for end-stage achalasia, a sigmoid esophagus, or a redundant conduit that has been used to replace the esophagus. This data will help researchers determine the safety and efficacy of a novel minimally invasive treatment compared to invasive surgery.
Read the detailed description
Researchers will be collecting electronic medical data for subjects who have already undergone Per-oral Plication of the Esophagus (POPE) procedure. Subject characteristics, radiographic documentation, videos, procedural details, and subject reported outcomes would be collected. This data will be used for review and analysis to answer questions aimed in this study. Data collected from this study will be entered into a database that will be maintained for future research.
- Conditions
- Achalasia
- Being tested
- POPE
- Keywords
- POPE
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POPEProcedure or surgery
Patients who have undergone Per-oral Plication of the Esophagus (POPE) procedure.
| Study group | Role | What they receive |
|---|---|---|
| POPE Patients | Patients who underwent POPE for end-stage achalasia, a sigmoid esophagus, or a redundant conduit that has been used to replace the esophagus. Receives: Procedure: POPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Evaluate safety by assessment of adverse events of the novel minimally invasive treatment compared to invasive surgery.
Measured: 01/01/2017-9/17/2018
Patient Reported Outcomes using the CONDUIT patient questionnaire.
Evaluate efficacy by reviewing patient reported outcomes of the novel minimally invasive treatment compared to invasive surgery.
Measured: 01/01/2017-9/17/2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start2 Oct 2018
- Primary completion19 Jan 2024
- Study completion19 Jan 2024
Why it stopped: PI left the institution before enrollment was complete.
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 Mayo ClinicThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shanda Blackmon, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875365
- Sponsor's protocol ID
- 18-007834
- Status last verified
- Mar 2024
- First submitted
- 18 Feb 2019
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Institutional Outcome Data From Per-oral Plication of the Esophagus (POPE)
- ClinicalTrials.gov ID
- NCT03875365
- Acronym / sponsor ID
- 18-007834
- Conditions
- Achalasia
- Keywords
- POPE
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left the institution before enrollment was complete.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 14 Mar 2019 (actual)
- 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.
Researchers are reviewing and analyzing surgical and clinical outcomes of subjects who underwent POPE for end-stage achalasia, a sigmoid esophagus, or a redundant conduit that has been used to replace the esophagus. This data will help researchers determine the safety and efficacy of a novel minimally invasive treatment compared to invasive surgery.
Detailed description
Researchers will be collecting electronic medical data for subjects who have already undergone Per-oral Plication of the Esophagus (POPE) procedure. Subject characteristics, radiographic documentation, videos, procedural details, and subject reported outcomes would be collected. This data will be used for review and analysis to answer questions aimed in this study. Data collected from this study will be entered into a database that will be maintained for future research.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POPE Patients | – | Procedure: POPEPatients who underwent POPE for end-stage achalasia, a sigmoid esophagus, or a redundant conduit that has been used to replace the esophagus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have already undergone Per-oral Plication of the Esophagus (POPE) procedure for end-stage achalasia, a sigmoid esophagus, or a redundant conduit that has been used to replace the esophagus.
Key inclusion criteria (2 listed)
- Adults > 18 years of age
- Patients who have already undergone Per-oral Plication of the Esophagus (POPE) procedure
Key exclusion criteria (1 listed)
- Patients <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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POPEPatients who have undergone Per-oral Plication of the Esophagus (POPE) procedure. | Procedure or surgery | POPE Patients |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 01/01/2017-9/17/2018
Evaluate safety by assessment of adverse events of the novel minimally invasive treatment compared to invasive surgery.
Patient Reported Outcomes using the CONDUIT patient questionnaire.
Time frame: 01/01/2017-9/17/2018
Evaluate efficacy by reviewing patient reported outcomes of the novel minimally invasive treatment compared to invasive surgery.
Results and safety
The study was stopped early (reason given: PI left the institution before enrollment was complete.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Shanda Blackmon principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achalasia, run by Mayo Clinic at 3 sites in United States.
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 2 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: stopped early, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The study was stopped early (reason given: PI left the institution before enrollment was complete.). Results are not available in the source record.
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?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 01/01/2017-9/17/2018). The study lists 2 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 11 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.