Status:
COMPLETED
Investigation to Evaluate Safety and Efficacy of the Endodrill Model X Biopsy Instrument
Lead Sponsor:
Region Skane
Collaborating Sponsors:
Bibb Instruments AB
Key2Compliance
Conditions:
Tumor Sampling
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is an investigator led prospective open label investigation, performed at three clinics in Sweden, comparing the flexible endoscopic biopsy instrument Endodrill Model X with the standard sampling...
Detailed Description
The investigation will include 20 patients with lesions and suspected tumors in the stomach, esophagus or duodenum (upper small intestine). The investigation will consist of one visit with an endoscop...
Eligibility Criteria
Inclusion
- Adults at least 18 years of age at the day of inclusion
- Signed informed consent
- Submucosal tumor of the upper gastrointestinal tract with tumor size ≥ 10 mm, well localized by the endoscopic examination
Exclusion
- Suspicion of vascular tumor (e.g. pulsating tumor)
- Ongoing treatment with anticoagulants (e.g. Warfarin)
- Ongoing treatment with immunosuppressive drugs
- Pregnancy
Key Trial Info
Start Date :
September 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2021
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04519138
Start Date
September 30 2020
End Date
November 30 2021
Last Update
December 2 2021
Active Locations (3)
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1
Linköping University Hospital
Linköping, Sweden, 581 85
2
Skane University Hospital
Lund, Sweden, 251 87
3
Örebro University Hospital
Örebro, Sweden, 701 85