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 @ 10:33 AM
Ignite Modification Date:
2025-12-26 @ 10:33 AM
NCT ID:
NCT04633928
Eligibility Criteria:
Inclusion Criteria:
* • Nasal septal perforation of a medium size (diameter 0.5 to 2.0 cm), measured by endoscopy
* Age above or equal to 18 years
* Informed Consent as documented by signature
* Patient is willing and able to give written informed consent to participate in the study and to comply with all study requirements, including attending all follow-up visits and assessments
Exclusion Criteria:
* • Nasal septal perforation of a small (\<0.5 cm) or large size (\>2.0 cm)
* Patient is smoking
* Known or suspected non-compliance, drug (especially cocaine) or alcohol abuse
* Evidence of infection with HIV or hepatitis B or C, syphilis. Patients with a cured hepatitis B or C infection and/or verified antibodies are not excluded.
* Known allergies to porcine collagen, penicillin or streptomycin
* Women who are pregnant or breast feeding
* Intention to become pregnant during the course of the study
* Chronic treatment with steroids or immunomodulatory drugs
* Diabetes
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol or in a dependency or employment with the sponsor.
* Patient is unable to understand the patient information
* Patient has a known systemic connective tissue disease.
* Patient has a known autoimmune disease.
* Patient has a known immunological suppressive disorder or is taking immunosuppressive.
* Patient is currently systemically or intra-articularly taking steroids and/or has used steroids within the 30 days prior to the planned treatment.
* The patient has at the site of surgery an active systemic or local microbial infection, eczematization or inflammable skin alterations (including Protozoonosis: Babesiosis, Trypanosomiasis (e.g. Chagas-Disease), Leishmaniasis, persistent bacterial infections, such as Brucellosis, spotted and typhus fever, other Rickettsiosis, Leprosy, Recurrent Fever, Melioidosis or Tularaemia).
* Patient has an active cancer.
* Patient is currently participating, or has participated in any other clinical study within 3 months prior to the screening visit.
* Patient has any other condition, which, in the opinion of the investigator, would make the patient unsuitable for the study.
* Patient is unable to tolerate local anesthesia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04633928
Study Brief:
Protocol Section:
NCT04633928