Drugdu.com expert's response:

Three-dimensional endoscopes typically require registration clinical trials, but the specifics of whether they are conducted and the requirements for clinical trials may vary based on product characteristics, registration region, and regulatory requirements.

Ⅰ. Clinical Trial Requirements for Three-dimensional Endoscopes

Regulatory Requirements: According to the relevant regulations of the National Medical Products Administration, medical devices generally need to provide clinical trial data during registration to prove their safety and effectiveness. As a type of medical device, three-dimensional endoscopes have certain complexity and risk in their design and use, thus usually requiring clinical trials to assess their performance.

Product Characteristics: Three-dimensional endoscopes feature three-dimensional imaging capabilities, providing a more three-dimensional surgical view and aiding doctors in making more accurate judgments and operations. However, this new technology may also bring some unknown risks and side effects, which need to be discovered and assessed through clinical trials.

Registration Region Differences: Different countries and regions may have varying registration requirements for medical devices. In some regions, three-dimensional endoscopes may be considered high-risk medical devices, requiring more stringent clinical trials to support their registration.

Ⅱ. Purposes and Requirements of Clinical Trials

Purposes: The main purpose of clinical trials is to assess the safety and effectiveness of three-dimensional endoscopes. Safety assessments include observing whether patients experience adverse reactions or complications when undergoing surgery with three-dimensional endoscopes. Effectiveness assessments focus on the application effects of three-dimensional endoscopes in surgery, such as surgical success rates, surgical duration, and postoperative recovery.

Requirements: Clinical trials should follow scientific, objective, and fair principles to ensure the authenticity and reliability of the data. The trial design should be reasonable, fully reflecting the performance and characteristics of three-dimensional endoscopes. Subjects should be fully informed and voluntarily participate in the trials, while their rights and safety should be guaranteed.

Ⅲ. Alternative Schemes for Clinical Trials

Although three-dimensional endoscopes usually require clinical trials to support their registration, in some cases, alternative schemes may exist:

Comparison with Similar Products: If a three-dimensional endoscope is similar in design, function, and usage to an already-marketed product, and the latter has sufficient safety and effectiveness data, then a comparison with similar products can be used to assess the performance of the three-dimensional endoscope.

Animal Trials: In some cases, animal trials may be considered an alternative to clinical trials.
However, the results of animal trials may not fully reflect the safety and effectiveness of human use, so they usually need to be combined with clinical trials for comprehensive assessment.

In summary, three-dimensional endoscopes typically require clinical trials during registration to assess their safety and effectiveness. However, the specifics of whether they are conducted and the requirements for clinical trials may vary based on product characteristics, registration region, and regulatory requirements. When formulating clinical trial protocols, the characteristics and risks of the product should be fully considered, and scientific, objective, and fair principles should be followed to ensure the authenticity and reliability of the data.