Clinical Study to CMDHA0101 as Compared to PowerFill® for Temporary Penile Enhancement
NCT ID: NCT03153735
Last Updated: 2017-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
68 participants
INTERVENTIONAL
2016-12-02
2017-11-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
\*Small-penis syndrome is the anxiety of thinking one's penis is too small - even though it isn't.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
If a subject signing a clinical trial agreement and satisfying the selection / exclusion criteria is enrolled in this clinical trial, he / she will receive the medical device for clinical testing at the baseline time, return to his / her home after the training . At 4 weeks, 12 weeks, and 24 weeks after the application of the medical device for clinical testing at baseline, the safety, penile girth, length, and satisfaction of the subject were evaluated. 24 weeks after application, the clinical trial sponsor (or trustee) retrieves the data necessary for the analysis of results, such as case records, for the purpose of validity and safety evaluation
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CMDHA0101
Maximum injection dose : 22 ml It is a product containing 0.3% lidocaine hydrochloride, a topical anesthetic ingredient, in a crosslinked hyaluronic acid gel
CMDHA0101
Maximum injection dose : 22 ml
PowerFill®
Maximum injection dose : 22 ml A white solid that was lyophilized with mixed spherical PLA (Poly-D, L-lactide) microparticles and CMC (sodium carboxymethylcellulose)
PowerFill®
Maximum injection dose : 22 ml
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CMDHA0101
Maximum injection dose : 22 ml
PowerFill®
Maximum injection dose : 22 ml
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
20 Years
65 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CHA MEDITECH Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dae Yul Yang, Director
Role: STUDY_DIRECTOR
Hallym University Kangdong Sacred Heart Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gangdong Sacred Heart Hospital, Hallym Univ
Seoul, Gangdong-gu/Gil-dong 445, South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHA-CMDHA0101
Identifier Type: -
Identifier Source: org_study_id