Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
PI left the institution before enrollment was complete.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POPE | Procedure | Patients who have undergone Per-oral Plication of the Esophagus (POPE) procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 01/01/2017-9/17/2018 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shanda Blackmon | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Mayo Clinic in Florida |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D004931 | Esophageal Achalasia |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C057561 | 1-palmitoyl-2-oleoylphosphatidylethanolamine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| D004066 | Digestive System Diseases |