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Endodrill vs. Conventional Biopsy. Diagnostics and Genetic Analysis

NCT02601079 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2020-03-17

No results posted yet for this study

Summary

Endodrill is a new instrument for biopsy sampling in the GI-channel. The purposes of this study are as follows:

* Compare the Endodrill instrument with conventional biopsy forceps in terms of ability to establish the correct diagnosis based on collected biopsies of tumors in the upper GI tract.
* Based on the quality of the collected tissue samples we want to evaluate which instrument generates the most useful material for genetic studies of the tumor.

Conditions

  • Esophageal Neoplasm

Interventions

DEVICE

Endodrill Biopsy

Testing a new device for taking tissue biopsies in the GI tract. The investigators will use the Endodrill instrument in order to sample high quality biopsies from tumor tissue in the distal esophagus and cardia. The investigators will also investigate to what extent the Endodrill instrument can generate biopsies with the correct diagnosis and also evaluate the possibility for genetic studies of the harvested tumor tissue.

DEVICE

Conventional Biopsy forceps

Using a conventional biopsy forceps for taking tissue biopsies in the GI tract. The investigators will use conventional biopsy forceps in order to sample high quality biopsies from tumor tissue in the distal esophagus and cardia. The investigators will also investigate to what extent the conventional biopsy forceps can generate biopsies with the correct diagnosis and also evaluate the possibility for genetic studies of the harvested tumor tissue.

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Principal Investigators

  • Jan Johansson, SrConsultant · Region Skåne

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2019-05-30
Completion
2019-06-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02601079 on ClinicalTrials.gov