Recruiting

Observational Study

Sponsor:

Weill Medical College of Cornell University

Code:

NCT03065257

Conditions

Gastrointestinal Neoplasms

Gastrointestinal Disease

Gastric Cancer

Gastric Neoplasm

Gastric Polyp

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endoscopic Resection

Study Details

Brief summary:

This is a retrospective and prospective multicenter registry to collect long-term data (1 year) on patients who have or will undergo Endoscopic resection such as EMR, ESD, EFTR, STER, etc. within the gastrointestinal tract for endoscopic treatment of early gastrointestinal neoplasms involving the resection of the superficial layers, mucosa and submucosa, of the tract wall.

Subjects will be consented for medical chart review.

The purpose of this retrospective and prospective registry is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Resection within the gastrointestinal tract (1 year).

The registry will evaluate efficacy, technical feasibility, clinical outcome, safety profile and overall clinical management through medical chart review. The procedures the investigators are evaluating are all clinically indicated and will not be prescribed to someone to participate in this registry study.

Conditions

Gastrointestinal Neoplasms

Gastrointestinal Disease

Gastric Cancer

Gastric Neoplasm

Gastric Polyp

Study ID

NCT03065257

Start date

Mar 15, 2017

Status verified date

Apr, 2017

Completion date

Apr, 2020

Anticipated

Primary completion date

Mar, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Any patient who is considering undergoing endoscopic resection within 6 months, or has undergone clinically indicated endoscopic resection within the past 6 months
  • Above or equal to 18 years of age.

Exclusion Criteria:

  • Any patient who has not undergone or will undergo endoscopic resection
  • Below 18 years of age.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Endoscopic Resection

Patients undergoing Endoscopic Resection

Interventions

Endoscopic Resection

Any Endoscopic resection for Gastrointestinal disorders including neoplasms.

Primary outcome measure

  • Number of participants with reduction in clinical symptoms [ Time Frame: 6 months from procedure ]

Central Contacts and Locations

Central contacts

Michel Kahaleh, MD

646-962-4797mik9071@med.cornell.edu

Monica R Gaidhane, MPH

646-962-4796mog2012@med.cornell.edu

Locations

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10065

Contacts

Michel Kahaleh, MD

646-962-4797mik9071@med.cornell.edu

Monica R Gaidhane, MPH

646-962-4796mog2012@med.cornell.edu

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Apr 25, 2017

Last verified

Apr, 2017

Keywords

  • EMR
  • ESD
  • Resection
  • STER
  • EFTR
  • Submucosal dissection
  • Endoscopic resection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2017-04-25.