Clinical Trial Design Considerations for Single-Port Laparoscopic Surgical Systems for Gynecological Surgery
1. Clinical Trial Objective
The objective of the clinical trial is to confirm the safety and effectiveness of the single-port laparoscopic surgical system in assisting physicians during surgery. Various methods can be employed including model tests, animal tests, and clinical trials. Based on comprehensive model and animal tests that confirm product performance and safety, a scientifically reasonable clinical trial should be designed. The clinical trial's objective is to verify the product’s effectiveness and safety in assisting endoscopic surgeries.
2. Overall Clinical Trial Design
The laparoscopic surgical system is a general-purpose surgical tool that assists physicians in completing surgical operations. For product registration, representative common gynecological surgical procedures should be selected for the clinical trial to support the registration application. The trial can adopt a prospective, single-group target value design.
3. Inclusion and Exclusion Criteria
The subjects are patients scheduled for gynecological representative procedures using the laparoscopic surgical system, as determined by trained physicians according to clinical diagnostic standards. The specific inclusion and exclusion criteria should be discussed and decided upon by the sponsor and the researchers.
4. Evaluation Indicators and Follow-Up Time
Primary Endpoints:
- *Primary Efficacy Endpoint:* The non-conversion rate of the surgery, defined as the proportion of surgeries not converted from the laparoscopic surgical system-assisted method to another laparoscopic system, laparoscopic surgery, or open surgery.
- *Primary Safety Endpoint:* The incidence rate of device-related or possibly device-related complications meeting the Clavien-Dindo classification system grade 3 or higher, from the first incision to 30 days post-operation.
Secondary Endpoints:
- Surgery duration
- Estimated intraoperative blood loss (mL)
- Patient pain scores
- Blood transfusion rate
- Incidence of device failures
- Length of hospital stay
- Overall complication rate from the first incision to 30 days post-operation (Clavien-Dindo grade 1 or higher)
- Incidence of adverse events and serious adverse events
- 30-day readmission rate
- Reoperation rate within 30 days
- Mortality rate within 30 days
5. Sample Size for the Clinical Trial
Before starting the clinical trial, the sponsor must collect comprehensive clinical data of similar products of a certain quality and quantity, and after scientific analysis (e.g., Meta-analysis), establish a target value for the clinical trial (performance target) including the target value and the one-sided confidence interval limit (usually 97.5% one-sided confidence interval). The sponsor must provide the basis for the determination of the target value and supporting documentation.
For example, if scientific analysis shows an acceptable minimum standard of non-conversion rate of 90%, and the expected non-conversion rate of the product is 99%, with a bilateral significance level of 0.05, power of 80%, and dropout rate of 10%, the sample size estimation using the exact probability method results in a sample size of 60 cases. If the industry-accepted minimum standard of complications meeting Clavien-Dindo grade 3 or higher within 30 days post-operation is 16%, and the product’s expected rate of these complications is 3%, using a bilateral significance level of 0.05, power of 80%, and dropout rate of 10%, results in a sample size estimation of 48 cases. Combining these, the total sample size for the clinical trial is 60 cases.
6. Clinical Trial Procedures
The clinical trial should cover common representative gynecological procedures, typically higher risk/more complex procedures. According to the “Management Specifications of the Clinical Application of Gynecological Endoscopic Diagnosis and Treatment Technologies (2019 Edition),” and considering that comprehensive staging surgery for endometrial cancer includes radical hysterectomy with pelvic lymph node dissection, representative procedures may include “radical hysterectomy with pelvic lymph node dissection” and/or “comprehensive staging surgery for endometrial cancer,” involving tasks such as grasping, cutting, suturing, coagulating, traction, dissecting, and ligating. If not all these representative procedures are included in the clinical trial, the application scope should specify “the product is used by physicians to control minimally invasive surgical instruments for gynecological laparoscopic surgery (excluding malignant lesions).”
7. Statistical Analysis
The clinical trial results should be statistically analyzed following the “Guidelines for the Design of Medical Device Clinical Trials,” to draw conclusions.