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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02744651
Other study ID # Endodrill III
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 17, 2017
Est. completion date December 31, 2021

Study information

Verified date January 2022
Source Region Skane
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Endodrill is a new instrument for biopsy sampling in the GI-channel. The purpose of this study is as follows: - Compare EUS-guided Endodrill biopsies with endoscopic ultrasound guided fine needle aspiration (EUS-FNA) in terms of ability to establish the correct diagnosis of submucosal tumors in the upper GI tract.


Description:

Endodrill is a newly constructed biopsy tool for flexible endoscopic use. It uses a drilling motion within a casing to harvest solid biopsies from tissue through the biopsy channel of a conventional flexible endoscope. It was originally designed for sampling of tissue from submucosal lesions. The investigators first study of the instrument is now finished. Endodrill is safe to use and generates more submucosal tissue compared to biopsies with a conventional biopsy forceps. In this study the investigators want to compare the Endodrill instrument with FNA (both modalities EUS-guided) in terms of ability to obtain the correct diagnosis of submucosal tumors in the upper GI-tract. Patients diagnosed with suspected submucosal tumors in the upper GI-tract will be enrolled to this study. They will first go through examination with EUS. If the suspicion of a submucosal tumor is confirmed, the investigator will perform both EUS guided FNA and Endodrill biopsies in the same patient.The harvested tissue will be evaluated by senior pathologists to clarify which method that generates most correct diagnosis.


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - All patients with a suspected submucosal tumor in the upper GI tract that are available for both EUS-guided FNA and Endodrill biopsy Exclusion Criteria: - Mental illness - Extreme co-morbidity

Study Design


Related Conditions & MeSH terms


Intervention

Device:
EUS-FNA
Please note the text in section "Arm description"
EUS-Endodrill biopsy
Please note the text in section "Arm description"

Locations

Country Name City State
Sweden University Hospital of Lund Lund Skane

Sponsors (1)

Lead Sponsor Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of correct histopathological diagnoses from submucosal tumors in the upper GI tract. Number of biopsies with the correct histopathological diagnoses 24 months
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