Trial Outcomes & Findings for SharkCore Versus Acquire FNB (NCT NCT03672032)

NCT ID: NCT03672032

Last Updated: 2021-07-13

Results Overview

A pathologist blinded to clinical information will access each Biopsy specimen for adequacy (scoring system where scores of 0 were samples with no material, 1 - sufficient material for adequate histological interpretation, low quality (total material \<10x power field in length), 2 - sufficient material for adequate histological interpretation, high quality (\>10x power field in length)

Recruitment status

COMPLETED

Study phase

Target enrollment

134 participants

Primary outcome timeframe

12 months

Results posted on

2021-07-13

Participant Flow

Unit of analysis: Lesions

Participant milestones

Participant milestones
Measure	SharkCore Needle SharkCore Needle: SharkCore Needle will be used to obtain biopsy	Acquire Needle Acquire Needle: Acquire Needle will be used to obtain biopsy
Overall Study STARTED	67 75	67 75
Overall Study COMPLETED	67 75	67 75
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SharkCore Versus Acquire FNB

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fork-tip Needle n=67 Participants Fork-tip Needle: Fork-tip Needle will be used to obtain biopsy	Franseen Needle n=67 Participants Franseen Needle: Franseen Needle will be used to obtain biopsy	Total n=134 Participants Total of all reporting groups
Age, Continuous	63.81 Years STANDARD_DEVIATION 12.49 • n=5 Participants	65.90 Years STANDARD_DEVIATION 12.34 • n=7 Participants	64 Years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	30 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	37 Participants n=7 Participants	70 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	67 Participants n=5 Participants	67 Participants n=7 Participants	134 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Histology Adequacy Score (0-2)

Outcome measures

Outcome measures
Measure	Fork-tip Needle n=75 Lesions Fork-tip Needle: Fork-tip Needle will be used to obtain biopsy	Franseen Needle n=75 Lesions Franseen Needle: Fransee Needle will be used to obtain biopsy
Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Histologic Yield of the Sample Obtained? 1, Sufficient, low quality	10 Lesions	14 Lesions
Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Histologic Yield of the Sample Obtained? 2, Sufficient, high quality	62 Lesions	57 Lesions
Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Histologic Yield of the Sample Obtained? 0, Insufficient	3 Lesions	4 Lesions

SECONDARY outcome

Timeframe: 12 months

Population: Combined diagnostic accuracy

The diagnostic accuracy was calculated considering malignant diagnoses as a true positive. A histological or cytological diagnosis of a neoplastic lesion will be considered correct since false-positive diagnoses have been reported to be rare if strict cytological criteria are applied. The criterion standard for diagnosis of benign, non-neoplastic lesion that will not undergo surgical resection will be based on a combination of clinal impression, imaging characteristics and a clinical course that was consistent with the study diagnosis.

Outcome measures

Outcome measures
Measure	Fork-tip Needle n=75 Lesions Fork-tip Needle: Fork-tip Needle will be used to obtain biopsy	Franseen Needle n=75 Lesions Franseen Needle: Fransee Needle will be used to obtain biopsy
Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Diagnostic Accuracy?	69 Lesions	65 Lesions

SECONDARY outcome

Timeframe: 12 months

Population: Needle passes

We will be collecting data on how many needle passes are required to get adequate FNB sample for each procedure. In the end, we will use this data to calculate using standard statistical measures to compare the average number of passes required to get adequate sample by both SharkCore and Acquire needle.

Outcome measures

Outcome measures
Measure	Fork-tip Needle n=75 Lesions Fork-tip Needle: Fork-tip Needle will be used to obtain biopsy	Franseen Needle n=75 Lesions Franseen Needle: Fransee Needle will be used to obtain biopsy
Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Number of Needle Passes Required to Obtain the Tissue Sample?	3 number of needle passes Interval 2.0 to 4.0	3 number of needle passes Interval 2.0 to 3.0

Adverse Events

Fork-tip Needle

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Franseen Needle

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fork-tip Needle n=67 participants at risk Fork-tip Needle: Fork-tip Needle will be used to obtain biopsy	Franseen Needle n=67 participants at risk Franseen Needle: Franseen Needle will be used to obtain biopsy
Hepatobiliary disorders Bleeding	0.00% 0/67 • 1 year	1.5% 1/67 • Number of events 1 • 1 year

Other adverse events

Other adverse events
Measure	Fork-tip Needle n=67 participants at risk Fork-tip Needle: Fork-tip Needle will be used to obtain biopsy	Franseen Needle n=67 participants at risk Franseen Needle: Franseen Needle will be used to obtain biopsy
Hepatobiliary disorders Pancreatitis	3.0% 2/67 • 1 year	4.5% 3/67 • 1 year
General disorders Abdominal Pain	6.0% 4/67 • 1 year	7.5% 5/67 • 1 year
Gastrointestinal disorders Nausea/Vomiting	1.5% 1/67 • 1 year	1.5% 1/67 • 1 year
Hepatobiliary disorders Cholangitis	1.5% 1/67 • 1 year	0.00% 0/67 • 1 year

Additional Information

Dr. Henning Gerke

University of Iowa Hospitals and Clinics

Phone: 319-384-6582

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place