Screening Visit. The Investigator is responsible for keeping a record of all patients screened for entry into the study, including those who are subsequently excluded. The reason(s) for exclusion must be recorded.
Screening Visit. The following procedures will be performed at the screening visit: • Written informed consent • Assign unique identifying number • Inclusion/exclusion criteria • Demographics • Physical examination • Medical history • Concomitant medications • Skin type (Xxxxxxxxxxx Scale) • Wrinkle evaluation (Xxxxxxxxxxx Xxxxxxx and Elastosis Scale) • Test spot Test Spot In order to assess tolerability to treatment, up to three test spots will be performed on the area adjacent to the ear on the side of the neck close to the back (so as it is not visible). Test spots should be based on skin type and desired outcome as per the chart below. The test spots will be used to determine the optimal parameters / setting combinations prior to the first treatment and later, the second treatment. o Following the test spot, wait to ensure that the chosen parameters indeed lead to the appropriate immediate response. o If slight erythema and edema and no adverse events occurred, treatment should be continued using the same setting or increase by not higher than ~10% parameters for each session. o If no results are observed, the treatment parameters should be increased. o If the patient has experienced adverse events along with improvement, the treatment parameters should be decreased. o Fine-tuning of the parameters can be done before proceeding to treat the entire sub-area with the chosen parameters. Modification of parameters per treated area within a treatment session should only be carried out if required due to safety concerns. Assessment of the test spot will be performed following at least 2 hours and up to 48 hours depending on skin type. As such, the first treatment may be conducted on the same day as screening. It is important to not start treatment prior to full evaluation of the reaction to the test spot and having optimal parameters identified.
Screening Visit. 2 Electronic bladder diary data may be reviewed by the site prior to Screening Visit 2. If there has been no issue with bladder diary completion (see Section 17.6) and the subject is ineligible (inclusion criterion #13, inclusion criterion #14, and exclusion criterion #28) then the subject may be considered as a “screen failure” at that point, and does not need to attend Screening Visit 2 (arrangements should be made to return the bladder diary device to the site). See Appendix 1 for details. The suggested order of procedures for Screening Visit 2 is shown in Table 7. Table 7 Order of Procedures for Screening Visit 2 Suggested order of procedures Comment Details of procedure
Screening Visit. Subjects presenting with heel pain will be examined to verify the diagnosis of plantar fasciitis. Then, subjects with plantar fasciitis will be screened to determine if they meet the study eligibility criteria. Prospective study participants will be informed of the study, and the requirements for study participation will be explained to them. Subject informed consent must be obtained prior to conducting screening procedures. Refer to Section 1.3 Schedule of Assessments, for activities to be performed. After the informed consent is obtained, the following procedures will be completed: • Physical examination • Foot and Ankle Examination of both feet (including range or motion and motor strength) • Collect xxxxx xxxxx (blood pressure [BP], pulse, temperature), weight, and height • Collect blood samples for clinical laboratory (chemistry, hematology, urinalysis), • Collect ECG if not done within the last six (6) months • Collect X-rays if not done within the last six (6) months • Collect concomitant medications/therapies, medical history information • VAS for pain for the foot to be completed by subject
Screening Visit. Treatment History Review: • Ascertain the patient has exudative AMD that has not resolved with anti-VEGF therapy: • Minimum of 3 prior anti-VEGF injections within the past 2-6 months, DURING WHICH • SD-OCT has shown recurrent or persistent macular fluid despite this anti-VEGF treatment, defined as the presence of significant subretinal fluid or cystoid macular edema, with macular thickness a minimum of 300 µm within the central macular subfield • Discuss the purpose and details of the study to the subject and obtain written informed consent prior to the subject's participation in any study related activity. • Review subject's demographic information, medical, surgical and medication history. • Perform the following: (all ophthalmic procedures to be performed OU) • Physical examination • Blood Pressure, Pulse Rate • EKG • BCVA (ETDRS) • Slit-lamp exam and biomicroscopy • IOP • Indirect ophthalmoscopy • SD-OCT • Review the inclusion and exclusion criteria. Do not continue screening any subject who does not meet the screening eligibility requirements. • If the subject continues to be eligible for the study, order and review the following tests to be performed at a local laboratory: • Serum pregnancy test (for females of child-bearing potential) • Hematology, serum chemistry • Upload all collected images to Sponsor or representative. • Schedule the subject to return for Baseline Visit (Day 0).
