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:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-25 @ 3:16 AM
NCT ID:
NCT06414005
Eligibility Criteria:
Inclusion Criteria:
1. Be 19 years of age or older.
2. Have partial-thickness rotator cuff tear, ≤50% of tendon thickness or of Ellman grade II assessed by MRI.
3. Have unilateral shoulder pain, muscle weakness and limited active range of motion lasting more than 3 months despite conservative treatment
4. VAS pain score ≥4 at screening.
5. Understand fully the study and voluntarily sign the informed consent for participation in the study.
Exclusion Criteria:
1. Regardless of partial-thickness rotator cuff tear, have full-thickness rotator cuff tear confirmed by MRI.
2. Have been treated with the following
* Have had painkiller within 1 week prior to screening visit.
* Have had received systemic steroid or immunosuppressive agents within 4 weeks prior to screening visit.
* Have had subacromial or intra-articular injections on the affected shoulder within 3 months prior to screening visit.
* Have shoulder surgery on the rotator cuff tear or had received drug that included growth factor, within 6 months prior to screening visit.
3. Have been diagnosed with the following diseases.
* Inflammatory joint diseases
* Other shoulder diseases which may cause shoulder pain or functional disorder
* Autoimmune diseases
* Active hepatitis B or C
* HIV Ab positive
* Malignant tumors within the last 5 years
* Coagulopathy
* Genetic disorders related to fibroblasts of collagen
* Other serious diseases deemed to affect the results of the study
4. Have allergies to bovine proteins or gentamicin.
5. Be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptive suggested in this study.
6. Have participated in other clinical trials and received investigational agents within 4 weeks of this study.
7. Be deemed inadequate for the study by investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT06414005
Study Brief:
Protocol Section:
NCT06414005