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Assessing the Preliminary Safety and Efficacy of the Transoral Robotic Surgery System for Minimally Invasive Head and Neck Tumor Resections: IDEAL phase 1

Assessing the Preliminary Safety and Efficacy of the Transoral Robotic Surgery System for Minimally Invasive Head and Neck Tumor Resections: IDEAL phase 1

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084806
Enrollment
Unknown
Registered
2024-05-24
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Head and neck disease

Interventions

Sponsors

Eye & ENT Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Age 18 to 75 years (inclusive of ages 18 and 75); 2) Gender: No restrictions; 3) Patients who meet the indications for minimally invasive surgery in pharyngeal and head and neck surgery, requiring TORS minimally invasive surgical treatment, such as those diagnosed with benign; pharyngeal and laryngeal tumors, T1-T2 stage and some T3 stage oropharyngeal cancer, laryngeal cancer, hypopharyngeal cancer, etc.; 4) Voluntarily participate in this trial and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with limited mouth opening; 2) Patients with neck lymph node metastases that are not amenable to surgical clearance; 3) Patients whose overall condition cannot tolerate general anesthesia; 4) Lymph node metastases that are fused and encasing major blood vessels; 5) Tumors with extensive infiltration into surrounding tissues, making minimally invasive surgery inappropriate; 6) Patients with poor overall condition that cannot be corrected despite preoperative treatment; 7) Patients with severe cardiac, pulmonary, hepatic, or renal diseases who cannot tolerate surgery; 8) Patients requiring emergency surgery due to disease conditions; 9) Patients who have been treated with systemic corticosteroids or immunosuppressants continuously in the past month; 10) Patients who are mentally incapable or unable to understand the requirements of participation in the study; 11) Pregnant or breastfeeding women; 12) Patients unwilling or unable to comply with medical advice; 13) Patients who have participated in another clinical trial within the past month; 14) Other conditions deemed inappropriate for inclusion by the researchers and medical staff.

Design outcomes

Primary

MeasureTime frame
Primary efficacy endpoint evaluation;Pain scores;Vital signs (body temperature, breathing, pulse, blood pressure);Physical examination;

Secondary

MeasureTime frame
Evaluation of equipment performance;Equipment defects;Tumor biomarkers;Physical status score;

Countries

China

Contacts

Public ContactLei Tao

Eye & ENT Hospital of Fudan University

doctortaolei@163.com+86 21 6437 7134

Outcome results

None listed

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