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Clinical trial evaluating the safety and effectiveness of laparoscopic assisted oral and maxillofacial surgery using an intra-abdominal endoscopic surgical system

Clinical trial evaluating the safety and effectiveness of laparoscopic assisted oral and maxillofacial surgery using an intra-abdominal endoscopic surgical system

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091960
Enrollment
Unknown
Registered
2024-11-06
Start date
2024-11-10
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Oropharyngeal cancer/oral cancer

Interventions

Sponsors

West China Stomatology Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) 18-80 years old (inclusive), male or female not limited; (2) Tumors can be well exposed orally; (3) The primary site is the oropharynx (including tonsils, soft palate, tongue base, and pharyngeal wall) and oral cavity; (4) Tumor patients who require radical surgery for oropharyngeal cancer, oral cancer, and preventive neck lymph node dissection, with stage T1-2N0M0. (5) Willing to cooperate and complete research follow-up and related examinations; (6) Those who voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with small jaw deformities and limited mouth opening; (2) Suffering from severe cardiovascular or circulatory system diseases or other intolerable surgical conditions; (3) Pregnant or lactating women, or women with pregnancy and childbirth plans during the study period; (4) History of epilepsy or mental illness; (5) Severe allergic constitution, suspected or diagnosed alcohol or drug addicts; (6) Unable to understand the research requirements or unable to complete the research follow-up plan; (7) General anesthesia is contraindicated; (8) Patients receiving re treatment in the same area; (9) Participants in clinical trials of other investigational drugs or devices within three months; (10) Accompanied by other malignant tumors or recurrence of the original tumor within five years; (11) The researcher considers it inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
Untransmission rate during surgery;Incidence of complications related or potentially related to the device;

Secondary

MeasureTime frame
Intraoperative blood loss and transfusion rate;Number of lymph node resections and surgical margins;Postoperative pain score;Overall incidence of surgical complications;Laboratory Examination;operative time;Postoperative hospitalization time;Equipment defect incidence rate;Incidence of adverse events and serious adverse events;

Countries

China

Contacts

Public ContactGuiquan Zhu

West China Stomatology Hospital, Sichuan University

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

Outcome results

None listed

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