Qualitative Validation of Patient-Reported Outcomes (PRO) Instrument

NCT ID: NCT03536715

Last Updated: 2018-05-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2017-06-22

Brief Summary

The purpose of this study is to conduct concept elicitation and cognitive debriefing interviews with patients who have been implanted with the KAMRA inlay in order to assess the content validity of a PRO instrument

Conditions

Patient-Reported Outcomes (PRO)

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Minimum 45 years of age, maximum age 60 years;

2. Subject has been implanted with the KAMRA inlay;

3. Subject is in good general health, as evidenced by medical history;

4. Subject is willing and able to attend and participate in the interviews and demographic questionnaire (fluent in U.S. English); and

5. Signed informed consent document.

Exclusion Criteria

1. Subject has severe neurological or cognitive deficits or an uncontrolled psychiatric condition that might affect their ability to participate in the interview;

2. Subject has insufficient ability to read or write that would prevent them from completing a questionnaire without help;

3. Subject is not a fluent speaker of U.S. English; or

4. Subject is unable to attend the interview.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AcuFocus, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

KAMR-201-PRO1

Identifier Type: -

Identifier Source: org_study_id