The DigniCap Scalp Cooling System has three primary components:
- Cooling Unit
- Cooling Wrap
- Thermal Cap
DigniCap Delta is a thermoelectric cooling unit with an integrated control system operated via touch screen monitor.
- DigniCap Delta operates by circulating temperature controlled DeltaCool from the device through a hose to the Cooling Wrap.
- The Wrap contains fluid channels that disperse the fluid to all surfaces of the Wrap.
- Circulating fluid temperature is monitored and precisely controlled by two separate sensors in the DigniCap Delta device, one that measures the fluid supply to the Cooling Wrap and one measuring fluid temperatures returning from the Cooling Wrap. An additional sensor monitors supply temperatures as a backup to assure patient safety.
- In 2015, DigniCap became the FIRST scalp cooling device to receive FDA clearance. After an extensive review of worldwide studies, in 2017 the FDA expanded the clinical indication for DigniCap to include men and women with solid tumors. DigniCap Delta, the next generation of The DigniCap Scalp Cooling System, was FDA cleared in June 2019.
- DigniCap Delta is the ONLY scalp cooling system that uses thermoelectric cooling for precise temperature control and device reliability.
- Superior results in the pivotal trial for FDA clearance:
DigniCap achieved 66.3% success with taxanes in the U.S. clinical trial vs the competitor’s success rate of 59% with taxanes and 50.5% overall.
- The advantage of this new generation (Delta) compared to the old one (C3) are as below:
- 54% smaller than C3 system
- Up to 80% reduction in nursing time
- Improved patient comfort from innovative thermoelectric cooling
- Quick connection
- Battery Power
- Intuitive user interface
- Single patient multiple-use cap (each cap can be used up to 10 session of chemotherapy)
- Flexible cooling wrap for precise fit for every size and shape of scalp.
- Single patient treatment
- 74.3% success with taxanes in the U.S. clinical trial.
The Cooling Wrap is designed to be wrapped around the patient’s head to create a custom fit for each patient.
- The Cooling Wrap is manufactured as a flat wrap that circulates temperature controlled fluid throughout channels in the cap.
- The fluid temperatures in the Cooling Wrap are tightly controlled by measuring the fluid temperature as it leaves the device and after the fluid returns to the device.
- The Cooling Wrap is completely adjustable to fit comfortably and uniformly on each patient.
- The Cooling Wrap is designed as Single Patient Use. The patient will keep the Cooling Wrap for their series of cooling sessions.
The Thermal Cap is designed to be worn over the Cooling Wrap to provide insulation and maintain scalp contact.
- The Thermal Cap is made of Neoprene to insulate the Cooling Wrap and prevent condensation.
- The Thermal Cap includes a chin strap to secure the cap.
- A series of adjustable tabs across the crown of the cap provide complete adjustability to assure a perfect fit.
- The Thermal Cap keeps the Cooling Wrap in place during treatment by virtue of its elasticity, thus ensuring optimum contact between the Cooling Wrap and the scalp.
- The Thermal Cap is intended for Single Patient Use. The patient will
keep the Thermal Cap for their series of therapy sessions.
DigniCap Delta consists of a thermoelectric cooling unit with a computerized control system operated via a touchscreen monitor. An adjustable Cooling Wrap is connected to the cooling unit. DeltaCool coolant is circulated from the device through the Therapy Hose to small channels within the Cooling Wrap. Circulating fluid temperature is monitored by two separate sensors in DigniCap Delta, one that measures the fluid supply to the Cooling Wrap and one measuring the return flow. An additional sensor monitors supply fluid temperatures as a backup to assure patient safety.
The Cooling Wrap can be easily disconnected from the DigniCap Delta device when necessary, for example, to facilitate restroom visits. To insulate and keep the Cooling Wrap in place, a neoprene Thermal Cap is used over the Cooling Wrap