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

Sponsor

Region Skane (Other)

Overall Status

Completed

CT.gov ID

NCT04519138

Collaborator

Bibb Instruments AB (Other), Key2Compliance (Other)

Enrollment

Locations

Arms

Actual Duration (Months)

2.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Tumor Sampling	Device: Endodrill Model X Device: Fine-needle aspiration/biopsy	N/A

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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Both the Endodrill Model X device and the standard instrument are used on the same lesion and patient to evaluate both instruments and their functions under as similar circumstances as possible.Both the Endodrill Model X device and the standard instrument are used on the same lesion and patient to evaluate both instruments and their functions under as similar circumstances as possible.

Masking:

None (Open Label)

Masking Description:

The order of the instruments to be used is blinded to the endoscopist until after the tumor has been visualized to avoid and minimize the influence of the choice of instrument of where the sample is taken. Closed envelopes prepared according to a randomization list stratified by site are available at each site. The envelope is opened by an assistant and not shown to the examiner until the tumor has been visualized.

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Sep 30, 2020

Actual Primary Completion Date :

Nov 30, 2021

Actual Study Completion Date :

Nov 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Endodrill Model X Three consecutive samples will be taken using the Endodrill Model X instrument.	Device: Endodrill Model X The investigational device Endodrill Model X is used for biopsy sampling in the upper gastrointestinal tract
Active Comparator: Endoscopic ultrasound guided fine-needle aspiration/biopsy Three consecutive samples will be taken using the the standard method fine-needle aspiration/biopsy.	Device: Fine-needle aspiration/biopsy The standard method is used for biopsy sampling in the upper gastrointestinal tract

Arm

Intervention/Treatment

Experimental: Endodrill Model X

Three consecutive samples will be taken using the Endodrill Model X instrument.

Device: Endodrill Model X

The investigational device Endodrill Model X is used for biopsy sampling in the upper gastrointestinal tract

Active Comparator: Endoscopic ultrasound guided fine-needle aspiration/biopsy

Three consecutive samples will be taken using the the standard method fine-needle aspiration/biopsy.

Device: Fine-needle aspiration/biopsy

The standard method is used for biopsy sampling in the upper gastrointestinal tract

Outcome Measures

Primary Outcome Measures

Proportion of patients with pre-specified adverse events [10 days]
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

Secondary Outcome Measures

Amount of visible biopsy material over or under 5 mm at endoscopy examination [Day 0 (day of biopsy)]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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