NCT00586872

Brief Summary

Existing records will be reviewed to evaluate the predictors of complications including stricture formation, bleeding or perforation associated with endoscopic mucosal resection

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 7, 2008

Completed
12.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2020

Completed
Last Updated

December 15, 2022

Status Verified

December 1, 2022

Enrollment Period

12.7 years

First QC Date

December 21, 2007

Last Update Submit

December 13, 2022

Conditions

Barrett's EsophagusEarly Esophageal Adenocarcinoma

Keywords

Endoscopic Mucosal Resection

Outcome Measures

Primary Outcomes (1)

  • Number and types of adverse events in participants who have undergone endoscopic mucosal resection with documented adverse events will be evaluated for predictors of complications

    analysis

    3 months after EMR procedure

Study Arms (1)

1

patients with barretts esophagus and/or early esophageal adenocarcinoma who have undergone endoscopic mucosal resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who have had endoscopic mucosal resection

You may qualify if:

  • Barrett's Esophagus Early Esophageal Adenocarcinoma History of Endoscopic Mucosal Resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Barrett EsophagusAdenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Cadman Leggett, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 7, 2008

Study Start

October 1, 2007

Primary Completion

June 4, 2020

Study Completion

June 4, 2020

Last Updated

December 15, 2022

Record last verified: 2022-12

Locations

US(1)