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Clinical trial to evaluate the safety and efficacy of the endoscopic surgical instrument control system (SP1000) in otolaryngology-head and neck surgery

Clinical trial to evaluate the safety and efficacy of the endoscopic surgical instrument control system (SP1000) in otolaryngology-head and neck surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095910
Enrollment
Unknown
Registered
2025-01-15
Start date
2024-04-02
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Throat and laryngeal tumors, thyroid diseases

Interventions

Experimental Group:The endoscopic surgical instrument control system (SP1000)

Sponsors

Zhejiang Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18-80 years (inclusive), regardless of gender; 2) Patients requiring surgical resection for throat, laryngeal tumors, or thyroid diseases who meet the following conditions: Benign tumors of the throat or larynx; T1 or T2 stage malignant tumors of the throat or larynx; Thyroid diseases suitable for endoscopic surgery; 3) No prior tumor treatment; 4) Willing and able to comply with the study protocol requirements; 5) Voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1)Previously received head and neck radiotherapy, regardless of whether chemotherapy was administered; 2)Evidence of other primary cancers or distant metastasis, or participants with synchronous primary tumors (excluding skin cancer); 3)Anticipated need for microvascular soft tissue reconstruction surgery before operation; 4)Tumor invasion and/or close proximity to the internal carotid artery and/or external carotid artery; 5)Pharyngeal posterior cervical artery combined with tonsil cancer or posterior wall cancer; 6)Evidence of tumor invasion into the mandible. 7) Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal to 2; 8) Currently using anticoagulant drugs and unable to stop them before surgery; 9) Contraindications to general anesthesia or surgery; 10) Mental disability or psychological disorders, or severe systemic diseases that prevent compliance with study requirements or inability to provide informed consent; 11) Pregnant or suspected pregnancy; 12) Difficulty in opening the mouth; 13) Thyroid tumors invading the trachea or esophagus, or extensive lymph node metastasis, with preoperative indications such as medullary carcinoma, poorly differentiated carcinoma, undifferentiated carcinoma, and invasive pathological subtypes of papillary thyroid carcinoma.

Design outcomes

Primary

MeasureTime frame
Rate of non-conversion surgery;Incidence of grade 3 or higher complications;

Secondary

MeasureTime frame
Surgery duration;Positive margin rate (%) [applicable to malignant tumors];Patient pain score;complication rate;Incidence of adverse events;

Countries

China

Contacts

Public ContactMinghua Ge

Zhejiang Provincial People's Hospital

geminghua@163.com+86 136 0581 3788

Outcome results

None listed

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