Investigation to Evaluate Safety and Efficacy of the Endodrill Model X Biopsy Instrument

Tumor Sampling Clinical Trial

Official title:

Safety and Efficacy of the Endodrill Model X Biopsy Instrument When Sampling Tumours in the Upper Gastrointestinal Tract

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04519138
• Other study ID #: BIBB EDMX01
• Status: Completed
• Phase: N/A
• Start date: September 30, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: November 2021
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 method endoscopic ultrasound fine needle aspiration/biopsy. Assessment of safety is the primary objective and performance is the secondary objective.

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 endoscopic examination with sampling of an observed lesion or suspected tumor. Six biopsies will be collected from each patient, three consecutive samples using the Endodrill Model X instrument and three consecutive samples using the standard fine needle. The order of instruments to be used will be randomly assigned. The patient will be under observation for 2 hours after the procedure. Telephone follow-up will be performed 1 and 7 days after the examination. Visual confirmation of the biopsies size will be recorded at the examination. If the samples verify a tumor or not will be evaluated at Day 14 when the pathology report is concluded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• Suspicion of vascular tumor (e.g. pulsating tumor)

• Ongoing treatment with anticoagulants (e.g. Warfarin)

• Ongoing treatment with immunosuppressive drugs

• Pregnancy

Related Conditions & MeSH terms

• Tumor Sampling

Intervention

Device:
• Endodrill Model X
The investigational device Endodrill Model X is used for biopsy sampling in the upper gastrointestinal tract
• Fine-needle aspiration/biopsy
The standard method is used for biopsy sampling in the upper gastrointestinal tract

Locations

Country	Name	City	State
Sweden	Linköping University Hospital	Linköping
Sweden	Skane University Hospital	Lund
Sweden	Örebro University Hospital	Örebro

Sponsors (3)

Lead Sponsor	Collaborator
Region Skane	Bibb Instruments AB, Key2Compliance

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with pre-specified adverse events	Proportion of patients with one or more of the following: 1) non-intentional perforation of the sampled organ, 2) bleeding requiring open surgical intervention or treatment at an intensive care unit, 3) non-planned hospitalization for observation AND where the patient is not fully recovered within 10 days after the endoscopic examination	10 days
Secondary	Amount of visible biopsy material over or under 5 mm at endoscopy examination	Visual confirmation of the biopsies size > 5 mm or not, will be recorded at the examination. Analysis will be performed at each hospitals department of pathology as all biopsy samples are routinely handled. A copy of the pathology report will recorded in the Contact Report Form (CRF) at day 14 when the study report for each patient is concluded	Day 0 (day of biopsy)