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Endodrill vs. Conventional Biopsy. Evaluation of Diagnostic Capacity in Diffuse Gastric Cancer

NCT02594943 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-11-26

No results posted yet for this study

Summary

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

* Compare the Endodrill instrument with conventional biopsy forceps in terms of ability to establish the correct diagnosis of diffuse gastric cancer based on collected biopsies from tumor tissue.

Conditions

  • Stomach Neoplasms

Interventions

DEVICE

Boston Scientific Large Capacity with needle Biopsy

The investigators will use a conventional biopsy forceps for taking tissue biopsies in the GI tract. In a randomized order 4 out of total 8 biopsies will be taken with the conventional biopsy forceps from the tumor tissue.

DEVICE

Endodrill 1A (BIBBInstruments, Lund, Sweden)

The investigators will use the Endodrill, a new device for endoscopic tissue sampling in the GI tract. In a randomized order 4 out of total 8 biopsies will be taken with the Endodrill instrument from the 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
2018-08-31
Primary Completion
2019-12-31
Completion
2019-12-31

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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 NCT02594943 on ClinicalTrials.gov