NCT02911363

Brief Summary

The main purpose of this study will be to two-fold; firstly to determine whether the use of a Captivator tissue cassette has an effect on the preservation of tissue histology (minimizing artifactual curling) , and secondly to determine whether the use of a intraprocedural cassette is practical. The investigators believe that this will greatly aid in elucidating the best technique for optimizing performance of EMR for esophageal lesions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

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

January 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

February 11, 2019

Status Verified

February 1, 2019

Enrollment Period

2.5 years

First QC Date

April 12, 2016

Last Update Submit

February 8, 2019

Conditions

Esophageal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Histological quality of the EMR specimen obtained during the procedure will be analyzed and compared to cassette vs. no cassette for pathology review.

    1\. Captivator tissue cassette vs. no cassette 1. Captivator tissue cassette with margin curling/artifact vs. Captivator tissue cassette without margin curling/artifact 2. No cassette with margin curling/artifact vs. no cassette without margin curling/artifact 3. Captivator tissue cassette with margin curling/artifact vs. No cassette with margin curling/artifact

    1 year

Secondary Outcomes (1)

  • Ease of use of the Captivator tissue cassette will be comparable to Standard of Care.

    1 year

Study Arms (2)

Capitvator Cassette

ACTIVE COMPARATOR

The EMR specimen will be processed using the Captivator Cassette.

Device: Captivator cassette

Standard of Care Processing

ACTIVE COMPARATOR

The EMR specimen will be prepared per Standard of Care.

Other: Standard of Care

Interventions

Captivator cassetteDEVICE

The Captivator tissue cassette has an effect on the preservation of tissue histology.

Capitvator Cassette
Standard of CareOTHER

The specimen will be processed following the College of American Pathology Standards.

Standard of Care Processing

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients referred to Florida Hospital Endoscopy Unit for assessment of an esophageal lesion that require EMR
  • Age ≥ 19 years

You may not qualify if:

  • Age \<19 years
  • Unable to safely undergo EMR for any reason
  • Coagulopathy (INR \>1.6, Thrombocytopenia with platelet count \<80,000/ml)
  • Unable to provide consent for any reason
  • Pregnancy (confirmed with Standard of Care urine pregnancy test for all women with child-bearing potential)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Interventional Endoscopy - Florida Hospital

Orlando, Florida, 32803, United States

Location

Related Publications (4)

  • Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.

    PMID: 23335087BACKGROUND

  • Devesa SS, Blot WJ, Fraumeni JF Jr. Changing patterns in the incidence of esophageal and gastric carcinoma in the United States. Cancer. 1998 Nov 15;83(10):2049-53.

    PMID: 9827707BACKGROUND

  • Blot WJ, McLaughlin JK. The changing epidemiology of esophageal cancer. Semin Oncol. 1999 Oct;26(5 Suppl 15):2-8.

    PMID: 10566604BACKGROUND

  • Lagergren J, Bergstrom R, Lindgren A, Nyren O. Symptomatic gastroesophageal reflux as a risk factor for esophageal adenocarcinoma. N Engl J Med. 1999 Mar 18;340(11):825-31. doi: 10.1056/NEJM199903183401101.

    PMID: 10080844BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Shantel Hebert-Magee, MD

    Florida Hospital Orlando

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2016

First Posted

September 22, 2016

Study Start

January 1, 2016

Primary Completion

July 1, 2018

Study Completion

August 1, 2018

Last Updated

February 11, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)