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Flexible Endoscopy Biopsies for Submucous Tumors With a New Drill Instrument

NCT02161029 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-02-01

No results posted yet for this study

Summary

The purpose of this study is to determine whether the newly constructed CE (Conformité Européenne) marked drill biopsy instrument for flexible endoscopes can make possible representative biopsies of the increasing numbers of submucosal tumours in the gastrointestinal tract. The amount of submucous tissue ( micrograms and in % of all the biopsy) harvested with the new drill biopsy instrument used in flexible endoscopy investigations is measured in the study and compared to the amount of submucous tissue harvested with the existing biopsy forceps.

Conditions

  • Gastric Tumor

Interventions

DEVICE

Flexible drill biopsy instrument

Biopsies taken with the new drill biopsy instrument for flexible endoscopy

DEVICE

conventional biopsy instrument

Biopsies taken with conventional biopsy forceps for flexible endoscopic instruments

Sponsors & Collaborators

  • Lund University

    collaborator OTHER

  • Lund University Hospital

    collaborator OTHER

  • Region Skane

    lead OTHER

Principal Investigators

  • Bruno S Walther, MD · Professor

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-02
Primary Completion
2015-03-27
Completion
2015-03-27

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 NCT02161029 on ClinicalTrials.gov