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A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Transoral Otolaryngology Surgeries

A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Transoral Otolaryngology Surgeries

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300078809
Enrollment
Unknown
Registered
2023-12-19
Start date
2023-07-27
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

Subjects who have received or plan to receive the treatment of benign lesions and T1 and T2 malignant tumors in oropharynx, hypopharynx and larynx with the SP single-port robot.

Interventions

Case series:None

Sponsors

Ruijin Hainan Hospital Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age: = 18, regardless of male or female; 2. Patients have received or plan to receive the treatment of benign lesions and T1 and T2 malignant tumors in oropharynx, hypopharynx and larynx with the SP single-port robot; 3. Patients who voluntarily decide to participate in the study and sign the ICF (or exempt from signature of the ICF as approved by the EC).

Exclusion criteria

Exclusion criteria: 1. Subjects having any contraindications of single-port robot surgery; 2. Patients with missing data on the primary endpoint in retrospective cases; 3. The intraoperative anatomy determined that minimally invasive surgery was not suitable; 4. Patients who are considered inappropriate to participate in this study by investigator.

Design outcomes

Primary

MeasureTime frame
Intraoperative conversion rate;: The incidence of device-related or likely related complications of Clavien-Dindo classification grade III or higher at postoperative 30 days;

Secondary

MeasureTime frame
Intraoperative bleeding volume;The rate of intraoperative blood transfusion;Surgical duration;Length of stay (LOS);Admission to ICU and ICU LOS;Pathologically confirmed positive surgical margin;Postoperative pain score;Short-term recovery of functions;

Countries

China

Contacts

Public ContactMingliang Xiang

Ruijin Hainan Hospital Shanghai Jiao Tong University School of Medicine

18917762275@163.com+86 189 1776 2275

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 3, 2026