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:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:39 PM
NCT ID:
NCT00466206
Eligibility Criteria:
Residents of the United States with previously diagnosed pectus excavatum who are referred to the UCSF Pediatric Surgery Service for evaluation and treatment will be considered for participation in this study. Only patients with moderate to severe pectus excavatum who meet all the inclusion criteria will participate. The patient and family will be fully counseled and consented about the risks and benefits of participation in the study, and will be asked to sign an informed consent reviewed and approved by the UCSF Committee on Human Research.
Inclusion Criteria:
1. Resident of the U.S.;
2. Otherwise healthy male or female with pectus excavatum deformity;
3. Between 8 and 14 years of age;
4. Pectus Severity Index \> 3.5 (normal 2.56); and
5. Ability to read and speak English.
Exclusion Criteria:
1. Other congenital anomalies (including significant skeletal anomalies such as scoliosis, bony fusion involving the cervical vertebrae) not directly related to pectus excavatum;
2. Bleeding disorders;
3. Heart disease (including arrhythmia);
4. Persons with active implantable medical devices (AIMD) such as pacemakers;
5. Persons with a relative(s) or close family friend(s) living within their households and having a pacemaker;
6. Persons with arteriovenous malformations;
7. Chest deformity more complicated than pectus excavatum (e.g.. Poland syndrome);
8. Persons for whom a foreign body implant would pose a risk (e.g., immunodeficiency);
9. Persons at increased risk for general anesthesia (e.g., history of malignant hyperthermia);
10. Respiratory conditions that have required steroid treatment (e.g., prednisone)in the last 3 years;
11. Pregnancy;
12. Inability to understand or follow instructions;
13. Refusal to wear the external brace;
14. Inability to obtain pre-approval (authorization) from the patient's insurance carrier; and
15. Inability or refusal to return to UCSF for weekly follow-up visits for the first month after surgery.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
14 Years
Study:
NCT00466206
Study Brief:
Protocol Section:
NCT00466206