JRCT ID: jRCTs072250143
Registered date:18/03/2026
A Clinical Study to Evaluate the Safety and Efficacy of a Novel Intraoperative Thoracoscopic Lens Cleaning Device
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Primary lung cancer, Metastatic lung tumor |
| Date of first enrollment | 18/03/2026 |
| Target sample size | 10 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | In thoracoscopic lobectomy performed on study participants, the number of times the endoscopic lens is wiped using the investigational device (the automated endoscopic lens cleaning system, OPLYS) will be evaluated as the primary endpoint. Secondary endpoints will include intraoperative complications, operative time, blood loss, length of hospital stay, duration of chest tube placement, incidence of postoperative complications, and surgeon satisfaction (operating surgeon and assistant). |
Outcome(s)
| Primary Outcome | Number of times the thoracoscopic camera lens is wiped |
|---|---|
| Secondary Outcome | Operation time, blood loss, duration of chest tube placement, length of hospital stay, questionnaire on usability, postoperative laboratory data (Hb, CRP, WBC, Alb), amount of drain output, need for blood transfusion, and postoperative complications. |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | 1. Patients undergoing thoracoscopic lobectomy with systematic lymph node dissection in the Department of Thoracic Surgery, Nagasaki University Hospital. 2. At the time of obtaining informed consent, only adults aged 18 years or older are eligible; sex is not restricted. 3. Written informed consent for participation in the study has been obtained from each patient. |
| Exclude criteria | 1. Patients with a history of ipsilateral thoracic surgery. |
Related Information
| Primary Sponsor | Matsumoto Keitaro |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Daisuke Taniguchi |
| Address | 1-7-1 Sakamoto, Nagasaki, Japan Nagasaki Japan 8528501 |
| Telephone | +81-958197304 |
| dt07dt29@gmail.com | |
| Affiliation | Nagasaki University Hospital |
| Scientific contact | |
| Name | Keitaro Matsumoto |
| Address | 1-7-1 Sakamoto, Nagasaki, Japan Nagasaki Japan 8528501 |
| Telephone | +81-958197304 |
| kmatsumo@nagasaki-u.ac.jp | |
| Affiliation | Nagasaki University Hospital |