Clinical Study on the Efficacy and Safety of Hypothermic Surgery System (AH-1) in the Treatment of Oral and Maxillofacial Benign Tumors

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300078567

Enrollment

Unknown

Registered

2023-12-12

Start date

2021-03-30

Completion date

Unknown

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign tumor of oral and maxillofacial region

Interventions

Experimental group:AH-1 treatment

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Subjects aged 18-75 (inclusive), regardless of gender; 2. Patients with benign tumors in oral and maxillofacial region with definite pathological diagnosis; 3. Single tumor, maximum diameter = 5cm; Or the number of tumors = 3, and the maximum diameter = 3cm; 4. ECOG-PS score = 2; 5. The expected life span exceeds three months; 6. Those who have not participated in other clinical verifications within 3 months; 7. Subjects voluntarily signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Severe liver, kidney, heart, lung, brain and other major organ failure; 2. The infectious and radioactive inflammation around the focus is not well controlled; 3. Have a history of immunodeficiency, including positive HIV test (ELISA and Western blot); 4. Severe bleeding tendency, platelet less than 50 × 10^9/L and severe coagulation disorder; 5. Coagulation index (PT, TT, APTT) > 2.5 times of upper limit of normal; 6. Serious heart and brain diseases or other mental diseases; 7. Poor general condition, multiple organ failure, cachexia, severe anemia and nutritional metabolism disorder; 8. Those who often use sedatives, sleeping pills, tranquilizers or other addictive drugs; 9. Pregnant or lactating women; 10. Those who can not determine the efficacy; 11. Other conditions determined by the investigator to be unsuitable for inclusion, such as intolerance of surgery, difficulty in follow-up, and other serious diseases.

Design outcomes

Primary

Measure	Time frame
Technical success rate;total effective rate;Tumor local recurrence rate and recurrence free survival rate;	—

Secondary

Measure	Time frame
Quality of life score;Subject tolerance;	—

Countries

China

Contacts

Public ContactJizhi Zhao

Peking Union Medical College Hospital

zhaojizhi@126.com+86 186 1267 1920

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026