Flexible Endoscopy Biopsies for Submucous Tumors With a New Drill Instrument
Flexible Endoscopy Biopsies With the New Drill Biopsy Instrument for Submucous Tumors
1 other identifier
interventional
10
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2014
CompletedFirst Posted
Study publicly available on registry
June 11, 2014
CompletedStudy Start
First participant enrolled
July 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2015
CompletedFebruary 1, 2019
January 1, 2019
9 months
March 25, 2014
January 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Amount of submucous tissue in gastrointestinal submucosal tumors harvested with a new drill biopsy instrument used with flexible endoscopes.
Amount of submucous tissue adequate for histological examination harvested with the new drill biopsy instrument for flexible endoscopy and compared to the amount harvested with the existing biopsy forceps in a randomized setting.
Within 30 days for each patient
Study Arms (2)
New drill biopsy instrument
ACTIVE COMPARATORTo take biopsies from gastric submucosal tumors with a new drill biopsy instrument used with flexible endoscopes.
Conventional biopsy instrument
ACTIVE COMPARATORTo take biopsies from gastric submucosal tumors with conventional biopsy forceps used with flexible endoscopes
Interventions
Biopsies taken with the new drill biopsy instrument for flexible endoscopy
Biopsies taken with conventional biopsy forceps for flexible endoscopic instruments
Eligibility Criteria
You may qualify if:
- Submucous gastrointestinal tumours
You may not qualify if:
- No gastrointestinal submucous tumor
- Submucosal hemangioma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
- Lund Universitycollaborator
- Lund University Hospitalcollaborator
Study Sites (1)
Department of Surgery, Lund University
Lund, SE-22185, Sweden
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruno S Walther, MD
Professor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 25, 2014
First Posted
June 11, 2014
Study Start
July 2, 2014
Primary Completion
March 27, 2015
Study Completion
March 27, 2015
Last Updated
February 1, 2019
Record last verified: 2019-01