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Kylon® Hooked-Fabric Biopsy Technology
Histologics LLC is proud to have developed Soft-ECC® endocervical curette, and the SoftBiopsy® exocervical gynecological biopsy device. Both devices employ a multipatented hooked fabric (Kylon®) that simultaneously biopsies with frictional raking/de-bonding of epithelium from stroma, and traps and stores the tissue for transport to the lab.
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 tip of the device comprised of rows of hooked fabric which collect and store the biopsy specimen is snapped free from the handle, and placed in the fixative vial where they are processed in the laboratory. Cervical biopsies are most commonly performed by pressing the device head onto the area of interest on the outer visible part of the cervix using simple rotation or key-turning like motions during colposcopy after an abnormal screening test. Use of the SoftBiopsy® produces multiple, small to moderate histological samples that are removed frictionally, not incision, and are consistent with multiple small 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
- Yetur P, Worsch L. Feasability to Diagnose Cervical Cancer During Colposcopy Using Fabric-Based Minimally Invasive Biopsy Devices. J Lower Gen Tract Dis, Volume 20, Number 2, Supplement 1, April 2016, p S22.
- Yetur P, Worsch L, Gao R, Tran AA. Photo-Micrographic Comparison of Spiral Bristle and Fabric-Based Minimally Invasive Exocervical Biopsies Relative to Punch Biopsy. J Lower Gen Tract Dis, Volume 20, Number 2, Supplement 1, April 2016, p S23.
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.
The Spirabrush CX® device was also invented at Histologics and is time-honored. It also removes abundant tissue from epithelial surfaces of the cervix. The tissue samples that are collected in the Spiral shaped stiff bristle array are snapped free from the handle, and placed in the fixative vial where they are 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 bristle brush grinds multiple trans-epithelial fragments to a depth under the basement membrane yeilding trans-epithelial fragments that are diagnostic.
Clinical trials documenting the utility of Spirabrush CX® have been presented and published:
- Monk B, Cestero RM, Cogan M, Lonky NM, Felix JC. SpiraBrush CX: A method of trans-epithelial cervical tissue sampling. Obstet Gynecol, 2002;100:1276-84.
- Tewari D, Lonky NM. Wilczynski SP, Rowley MN, Lonky SA, Johnson P. Transepithelial Sampling of the Uterine Ectocervix with a Stiff Bristled, Spiral-Shaped Brush. J Lower Genital Tract Dis. 2004: 8: 276-279.
- Sweet P 3rd, Chen J, Schultz JH. Spiral brush cervical biopsy experience in a community clinic. Eur Rev Med Pharmacol Sci. 2015;19(11):1973-5.