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To evaluate the safety and efficacy of the Endoscopic surgical system in a prospective, multi-center, single-arm clinical trial

To evaluate the safety and efficacy of the Endoscopic surgical system in a prospective, multi-center, single-arm clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091248
Enrollment
Unknown
Registered
2024-10-23
Start date
2024-10-31
Completion date
Unknown
Last updated
2024-10-28

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

Conditions

None

Interventions

Sponsors

West China Hospital of Stomatology Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years old, male or female; 2. Those who plan to undergo any of the following procedures with the endoscopic surgery system: (1)Transoral approach, oral and oropharyngeal tumor resection; (2)Cervical lymph node dissection, submandibular gland resection and parotidectomy; (3)Thyroidectomy, parathyroidectomy and mastectomy; (4)Liver tumor resection, Roux-en-Y choledochojejunostomy, local resection of pancreatic tumor,cystoduodenostomy for internal drainage of pancreatic pseudocysts, distal pancreatectomy, splenectomy and other hepatobiliary pancreatic surgery; (5)Other patients who were judged by the investigator to have indications for laparoscopic surgery; 3. The subjects fully understood the benefits and risks of the trial, were willing to participate in the trial and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Those with serious comorbidities (heart, lung, liver, brain, kidney and other diseases) or weak constitution that cannot tolerate general anesthesia or surgery; 2. Those with severe bleeding tendency or coagulation dysfunction; 3. Perioperative adjuvant therapy such as radiotherapy and chemotherapy is required; 4. Combined with surgical site or systemic infection, severe inflammatory reaction; 5. The lesions were adjacent to or invaded large vessels; 6. Pregnant and lactating women; 7. Epilepsy or psychiatric history; 8. Patients with previous surgical history suspected severe adhesion affecting the operation; 9. Severe obese patients with BMI=30 kg/m2 who were scheduled for abdominal surgery; 10. Patients who participated in any other clinical trials of drugs or medical devices within 3 months before surgery and did not complete them; 11. Subjects deemed by the investigator to be ineligible for participation in the trial.

Design outcomes

Primary

MeasureTime frame
Non conversion rate;The incidence of complications according to Clavien-Dindo classification system grade ? or above;

Secondary

MeasureTime frame
Medical device installation time;Operation time;Blood loss;Blood transfusion rate;Surgeon's satisfaction socre;Postoperative pain score;The length of hospital stay;Evaluation of postoperative incision;

Countries

China

Contacts

Public ContactGuiquan Zhu

West China Hospital of Stomatology Sichuan University

zhugq@scu.edu.cn+86 159 0289 1530

Outcome results

None listed

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