A number of clinical studies have been carried out to evaluate the safety and efficacy of the system:

1.    Lundgren-Eriksson et al. Total prevention of taxoid-induced alopecia by a new model of cold cap, ECCO 10, vol. 35, suppl 4. 12-16 Sept, 1999.

2.    Henriksen et al. Advanced computerised cold cap for preventing chemotherapy induced alopecia, Poster 1208, presented at ECCO 12 21-25 Sept. 2003.

3.    Ridderheim et al. Scalp hypothermia to prevent chemotherapy-induced alopecia is effective and safe: a pilot study of a new digitized scalp-cooling system used in 74 patients, Support Care Cancer, 2003 Jun;11(6):371–7.

4.    Byachov. Prophylaxis of alopecia in patients undergoing chemotherapy, presented at All-Russian Convention of Oncologists, 2006 and at Conference of Russian Mammological Society 2005. Published in Meditsinskaya Kartoteka, 2006.

5.    Kobayashi et al. Evaluation of the DigniCap™ system for the prevention of chemotherapy-induced hair loss in breast cancer patients, accepted for publication and presentation at the 16th Japanese Breast Cancer Society meeting, Sept 26–27, 2008.

Post-market Surveillance Report. A report on 2249 patients treated with the DigniCap™ system between 2001 and 2007 in Scandinavia. Nov 2007.