Trial Outcomes & Findings for 22G FNA Needle vs. 22G ProCore Needle (NCT NCT01394159)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

56 participants

Primary outcome timeframe

6 months

Results posted on

2018-03-09

Participant Flow

Participant milestones

Participant milestones
Measure	22G ProCore Biopsy Acquire biopsy with procore needle Procore Biopsy: Acquire tissue with procore biopsy needle	22G FNA Needle Acquire tissue with 22 gauge fine needle aspiration needle
Overall Study STARTED	28	28
Overall Study COMPLETED	28	28
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

22G FNA Needle vs. 22G ProCore Needle

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ProCore Biopsy n=28 Participants Acquire biopsy with procore needle Procore Biopsy: Acquire tissue with procore biopsy needle	FNA Needle n=28 Participants FNA: Acquire tissue with FNA needle	Total n=56 Participants Total of all reporting groups
Age, Continuous	65.0 years STANDARD_DEVIATION 15.4 • n=5 Participants	65.4 years STANDARD_DEVIATION 11.1 • n=7 Participants	65.2 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized White	22 participants n=5 Participants	21 participants n=7 Participants	43 participants n=5 Participants
Race/Ethnicity, Customized Black	6 participants n=5 Participants	7 participants n=7 Participants	13 participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	28 participants n=7 Participants	56 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	22G ProCore Biopsy n=28 Participants Acquire biopsy with procore needle Procore Biopsy: Acquire tissue with procore biopsy needle	22G FNA Needle n=28 Participants Acquire tissue with 22 gauge fine needle aspiration needle
Compare the Median Number of Passes Required to Establish a Diagnosis	1 No. of passes for diagnosis Interval 1.0 to 1.0	1 No. of passes for diagnosis Interval 1.0 to 2.5

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	22G ProCore Biopsy n=28 Participants Acquire biopsy with procore needle Procore Biopsy: Acquire tissue with procore biopsy needle	22G FNA Needle n=28 Participants Acquire tissue with 22 gauge fine needle aspiration needle
Diagnosis Achieved With the Needle	25 participants	28 participants

SECONDARY outcome

Timeframe: 6 months

Malfunction of the needle during endoscopic ultrasound-guided sampling of the pancreatic mass lesion before a diagnosis is achieved

Outcome measures

Outcome measures
Measure	22G ProCore Biopsy n=28 Participants Acquire biopsy with procore needle Procore Biopsy: Acquire tissue with procore biopsy needle	22G FNA Needle n=28 Participants Acquire tissue with 22 gauge fine needle aspiration needle
Technical Failure	1 participants	0 participants

Adverse Events

22G ProCore Biopsy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

22G FNA Needle

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	22G ProCore Biopsy n=28 participants at risk Acquire biopsy with procore needle Procore Biopsy: Acquire tissue with procore biopsy needle	22G FNA Needle n=28 participants at risk Acquire tissue with 22 gauge fine needle aspiration needle
Gastrointestinal disorders abdominal pain	0.00% 0/28	3.6% 1/28 • Number of events 1
Gastrointestinal disorders Mild acute pancreatitis	3.6% 1/28 • Number of events 1	0.00% 0/28

Additional Information

Dr Shyam Varadarajulu

Center for Interventional Endoscopy, Florida Hospital

Phone: 407-303-2570

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place