Histologics LLC is proud to have developed Soft-ECC® , the next best endocervical curette, and the SoftBiopsy® gynecological biopsy device.
The Soft-ECC® and SoftBiopsy® were developed with the patient care experience in mind. The Soft-ECC® design is intended to fit into most endocervical canals and yield an abundant biopsy sample. The ECC procedure is usually performed to remove tissue from the endocervical canal for histological analysis during colposcopy or during the diagnostic work-up of abnormal peri-menopausal or menopausal bleeding. Unlike cytobrush sampling which is a cytologic screening modality, Soft-ECC curettage produces diagnostic histological samples.
The SoftBiospy® device removes abundant tissue from epithelial surfaces of the cervix. The tissue samples that are collected in the fabric tip placed in the fixative vial along with the detached distal device tip, and processed in the laboratory. Cervical biopsies are most commonly performed during colposcopy after an abnormal screening test. SoftBiopsy® produces multiple small to moderate histological samples per use to the lab that are consistent with multiple small cervical punch biopsy samples.
The Kylon® fabric employed in these gynecologic tissue sampling devices captures and retains the specimen for transport. These Kylon® tipped devices are dually registered for clearance for sale with the FDA as both biopsy devices (gynecological biopsy or curette) and as Tissue Collection and Transport Systems because once the tissue is captured in the fabric base and snapped free, its function is as a non-sterile specimen container. The containment aspect of the system has been research-proven to retain an abundant sample for analysis in the lab.
Clinical trials documenting the utility of Soft-ECC® and SoftBiopsy® have been presented and published:
- Burg, et al. Trans-Epithelial Endocervical and Exocervical Biopsy with Minimally Invasive Fabric Based Devices. J. Lower Gen Tract DisVol. Sixteen, Number Two, April 2012 Supplement pg. S22
- Winter, et al. Fabric-Based Exocervical and Endocervical Biopsy in Comparison with Punch Biopsy and Sharp Curettage. J. Lower Gen Tract Dis., Vol. Sixteen, Number Two, April 2012 pg. 80-87.
- Diedrich et al. Improvement in Endocervical Yield with Fabric Curettage J. Lower Gen Tract Dis, April 2014 - Volume 18 - Supplement 1 5, p-S19.
- Clark et al. High Correlation of Fabric-based Cervical Biopsy to Subsequent LEEP. J. Lower Gen Tract Dis, April 2014 - Volume 18 - Supplement 1 5, p-S22.
- Clark et al. Observation of a Robust Immune Inflammatory Response Following Frictional Fabric Biopsy During Colposcopy. J Lower Gen Tract Dis, April 2014 - Volume 18 - Supplement 1 5, p-S21
Other clinical studies are just getting under-way to demonstrate the clinical utility of Kylon® fabric based tissue collection and storage systems that both capture and retain (contain) tissue during colposcopic histological sampling procedures.
Interested in bringing Soft-ECC® or SoftBiopsy® into your practice?