Good News | First Patient Enrolled in Pivotal Clinical Trial of Spray Cryoablation System for COPD Treatment

Table of Content [Hide]

Source: SensCure　

Date: Mar. 30, 2023　

Views: 5,565

On March 29, 2023, the spray cryoablation system for chronic obstructive pulmonary disease (COPD), independently developed by SensCure Biotech (Ningbo) Co., Ltd., successfully completed the national first patient enrollment in its pivotal clinical trial under the leadership of Professor Wang Changhui’s team at Shanghai Tenth People’s Hospital. A bronchoscopic spray cryoablation procedure was performed on a COPD patient, and the surgery proceeded smoothly.

good news first patient enrolled in pivotal clinical trial of spray cryoablation system for copd treatment

The symptoms had been troubling Mr. Chen. After learning about the innovative cryotherapy technology, he consented to undergo the bronchoscopic spray cryoablation procedure. The spray cryoablation procedure enrolled its first clinical trial subject, Mr. Chen, a 65-year-old man who was initially diagnosed with chronic obstructive pulmonary disease (COPD) in early 2013. Symptoms such as coughing and sputum production had persisted for years, worsening notably during seasonal transitions or significant temperature fluctuations. Prior to this, he had tried various treatment regimens, yet symptoms including cough, sputum, and shortness of breath persisted. During the procedure, a catheter is introduced via bronchoscopy to the target lesion site. The spray tip directly administers the ultra-low temperature cryogen—liquid nitrogen (−196°C)—onto the target tissue for cryoablation. The entire surgical procedure lasts approximately 30 minutes.

good news first patient enrolled in pivotal clinical trial of spray cryoablation system for copd treatment

Chronic obstructive pulmonary disease (COPD) is a common, preventable, and treatable chronic airway disease. As a prevalent condition that seriously endangers human health, it serves as a major cause of mortality and has emerged as the third leading cause of death globally and domestically, imposing a heavy economic burden on patients, families, and society. Currently, the primary treatment modality for COPD is pharmacological therapy. Sustained bronchodilator medication during the stable phase can alleviate COPD symptoms and reduce the frequency and severity of acute exacerbations. However, current drug therapies suffer from poor compliance, numerous adverse reactions, and suboptimal control efficacy, thus failing to meet clinical demands. Dysfunction of cilia, mucus hypersecretion, increased bacterial colonization, airway inflammation, and oxidative stress are key pathogenic mechanisms of COPD. Spray cryoablation represents a novel interventional therapy. It delivers liquid nitrogen circumferentially onto the surface of airway tissues via spray application. The ultra-low temperature of liquid nitrogen ablates hypertrophic and hyperplastic mucosal glands and goblet cells while preserving basal cells and the extracellular matrix. This process facilitates the rapid regeneration of healthy mucosa within a short timeframe, reduces mucus secretion, restores ciliary function, and achieves therapeutic efficacy.

good news first patient enrolled in pivotal clinical trial of spray cryoablation system for copd treatment

The spray cryoablation system independently developed by SensCure Biotech (Ningbo) Co., Ltd. consists of a spray cryoablation catheter and cryotherapy equipment. The cryoablation system features rapid cooling rates and precise temperature control. The spray tip can deliver liquid nitrogen at -196°C within an extremely short period, directly ablating target tissues with significant cryoablation efficacy. The team at Shanghai Tenth People's Hospital has completed treatment for 10 patients with chronic obstructive pulmonary disease (COPD) and conducted one-year follow-up, demonstrating favorable clinical outcomes. Patients showed improvements in quality of life, clinical symptoms, and exercise tolerance to varying degrees, with no device-related serious adverse events reported.

A multicenter pivotal clinical trial has been initiated nationwide to evaluate the efficacy and safety of bronchoscopic spray cryoablation for adult COPD. Twelve hospitals are currently participating in this joint study, aiming to provide a novel treatment option for COPD patients.

References

SensCure Showcases Innovations at the 2023 Shanghai International Digestive Endoscopy Symposium

Breaking | World's First Patient Enrolled in Pivotal Clinical Trial of Airway Cryotherapy System for Asthma Treatment