2 Attachment C – Optional Data Entry Form

---

Overview

Sheet1
Sheet2

---

Sheet 1: Sheet1

Manual Data Entry Form

Sponsor:

List of Completed Studies

Please provide a listing of all completed studies that your organization has sponsored for this indication.

In the list, please indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number.

Drug(s)/Device(s)/Other treatment(s):

NCT #:

Results:

For completed studies that are on ClinicalTrials.gov, but do not have results, please provide a summary with the following:

Drug(s)/Device(s)/Other treatment(s):

Study #:

Time Period:

Study Design:

Methodologies:

Indication & Diagnosis:

Propper Use Instructions:

Inclusion & Exclusion Criteria:

Primary & Secondary Outcomes:

Baseline Characteristics:

# of Patients:

Effectiveness & Efficacy:

Safety Results:

Screened:

Eligible:

Enrolled:

Lost to Follow-up:

Withdrawn:

Analyzed:

Screened:

Eligible:

Enrolled:

Lost to Follow-up:

Withdrawn:

Analyzed:

Screened:

Eligible:

Enrolled:

Lost to Follow-up:

Withdrawn:

Analyzed:

List of Ongoing Studies

Please provide a list of ongoing studies that your organization has sponsored for this indication.

In the list, please provide the ClinicalTrials.gov trial number.

Drug(s)/Device(s)/Other treatment(s):

NCT #:

If a trial or study is not registered on ClinicalTrials.gov, please provide the protocol for the study including the following data:

Drug(s)/Device(s)/Other treatment(s):

Study #:

Time Period:

Study Design:

Methodologies:

Indication & Diagnosis:

Propper Use Instructions:

Inclusion & Exclusion Criteria:

Primary & Secondary Outcomes:

---

Sheet 2: Sheet2

yes

no