14 g vs. 16 g in Breast Biopsy | NCT03212040 | Trialant

14 g vs. 16 g in Breast Biopsy | NCT03212040 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
14 gauge needle biopsy	Active Comparator	breast biopsy will be performed with 14 gauge needle	Diagnostic Test: needle biopsy
16 gauge needle biopsy	Active Comparator	breast biopsy will be performed with 16 gauge needle	Diagnostic Test: needle biopsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic accuracy	Diagnostic aggreement (representativity) with definitive histology of core needle specimen and of surgical specimen Additive diagnostic aggreement (representativity) with definitive histology of core needle specimen and with histology of surgical specimen, with 1 to 5 passes of core needle biopsy Additive diagnostic accuracy to achieve a high (>=99%) diagnostic yield, with 1-5 passes of core needle biopsy	1 year
Diagnostic quality	Diagnostic quality of specimen to achieve an accurate histological diagnosis Diagnostic quality of specimen to achieve an accurate histological diagnosis, with 1 to 5 passes of core needle biopsy Additive diagnostic quality to achieve a high (>=99%) diagnostic yield, with 1-5 passes of core needle biopsy	1 year

Secondary Outcomes

Measure	Description	Time Frame
Pain related to the biopsy procedure	Subjective pain perception measured visual analog scale	1 year
Duration time of the biopsy procedure	Duration time of the biopsy procedure

Intervention Browse Module