Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-24 @ 10:12 PM
NCT ID:
NCT03153735
Eligibility Criteria:
Inclusion Criteria:
1. Men over 20 years old and under 65 years of age
2. In screening, subjects' perception of penile size for dysmenorrhoea syndrome Those who responded with "small", "small", "normal", "large", "very large"
3. Persons who have agreed to discontinue other procedures or treatments for penile enlargement during the course of the trial
4. If the person is circumcised or has not undergone circumcision, A person who does not cover the glans
5. Those who have agreed to abstinence (sexual intercourse, masturbation, etc.) for at least one month after the medical device for clinical trial
6. Those who can understand and follow instructions
7. A person who voluntarily participates in the clinical trial and has agreed in writing to the subject consent form
Exclusion Criteria:
1. A person who has received anticoagulant or antiplatelet agent within 2 weeks before application of medical device for clinical trial or Those who need to be administered until two weeks after application (However, low-dose aspirin (300 mg / day or less) is permitted.
2. A person who has received a vitamin E preparation, NSAID preparation within 1 week of application of medical device for clinical trial or Those who need to take medicine until 1 week after application
3. Those who have a history of bleeding in past or present time
4. Persons who are adversely affected by excessive penis enlargement, which may adversely affect the operation of the medical device
5. Those who have undergone penis enlargement surgery (fat, alternative dermatologic transplantation) in the past (except for hyaluronic acid or collagen. Two years after transplantation and extension of the penis, such as suprapubic fat preparation and suspension ligament resection In the case of surgery, it is allowed.)
6. Peyronie's disease of the penis (Peyronie's disease) malformation
7. Anaphylaxis or severe allergic symptoms.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT03153735
Study Brief:
Protocol Section:
NCT03153735