NCT02161029|Completed
Flexible Endoscopy Biopsies for Submucous Tumors With a New Drill Instrument
Flexible Endoscopy Biopsies With the New Drill Biopsy Instrument for Submucous Tumors
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Flexible Endoscopy Biopsies With the New Drill Biopsy Instrument for Submucous Tumors
Sponsor study identifier
interventional
10
1 country
1
Study Start
July 2, 2014
Actual (reported)Primary Completion
March 27, 2015
Actual (reported)Study Completion
March 27, 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 27, 2015
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 25, 2014
Actual (reported)June 11, 2014
Actual (reported)July 2, 2014
Actual (reported)March 27, 2015
Actual (reported)March 27, 2015
Actual (reported)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
To take biopsies from gastric submucosal tumors with a new drill biopsy instrument used with flexible endoscopes.
To take biopsies from gastric submucosal tumors with conventional biopsy forceps used with flexible endoscopes
Biopsies taken with the new drill biopsy instrument for flexible endoscopy
Biopsies taken with conventional biopsy forceps for flexible endoscopic instruments
Department of Surgery, Lund University
Lund, SE-22185, Sweden
Bruno S Walther, MD
Professor
10 participants (actual enrollment reported by the registry).
First Submitted
March 25, 2014
First Posted
June 11, 2014
Study Start
July 2, 2014
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 27, 2015
Actual (reported)Study Completion
March 27, 2015
Actual (reported)Last Updated
February 1, 2019
Record last verified: 2019-01
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Source: ClinicalTrials.gov.
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