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The clinical trial to evaluate efficacy and safety of bronchoscope navigation control system and catheter with prospective, multicenter, single group target value method for the localized biopsy of peripheral pulmonary nodules

The clinical trial to evaluate efficacy and safety of bronchoscope navigation control system and catheter with prospective, multicenter, single group target value method for the localized biopsy of peripheral pulmonary nodules

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200067234
Enrollment
Unknown
Registered
2022-12-30
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Pulmonary nodule

Interventions

Intervention Group:bronchoscope navigation control system guided lung nodule biopsy

Sponsors

The First Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years, no gender limit; 2. Patients diagnosed with peripheral pulmonary nodule require biopsy; 3. Patients agree to receive bronchoscopic procedure and meet the requirements of bronchoscopy; 4. Patients who can understand the objectives of study, have good compliance with the tests and follow-up, agree to participate in the clinical trial and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Female patients who are breastfeeding or pregnant or preparing for pregnancy; 2. Patients with electromagnetic active implants in their bodies; 3. The patient is allergic to anesthetic; Or have multiple history of severe allergies, genetic allergies; 4. Participated in or is participating in clinical trials of drugs within 3 months prior to screening, or participated in clinical trials of other medical devices within 30 days prior to screening; 5. Other conditions deemed unsuitable for participation in this clinical trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Diagnostic yield;

Secondary

MeasureTime frame
The successful reach rate of bronchoscope navigation control system and catheter;The detection rate of bronchoscope navigation control system and catheter;Performance evaluation of the medical device ;

Countries

China

Contacts

Public ContactLi Shiyue

The First Hospital of Guangzhou Medical University

lishiyue@188.com+86 13902233925

Outcome results

None listed

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