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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Study Status Progress Inadequate
Application Number P140008 / PAS001
Date Current Protocol Accepted 08/21/2017
Study Name OSB Lead-ORBERA PAS (OPAS-001)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, multicenter, open-label new enrollment post-approval study of the safety and effectiveness of ORBERA as an adjunct to weight reduction for obese adults (22 years of age and older) with a Body Mass Index (BMI) of greater than or equal to 30 kg/m2 and BMI of less than or equal to 40 kg/m2. Treatment includes behavioral modification program in conjunction with endoscopic placement of a single ORBERA Intragastric Balloon, filled with saline to an inflation volume between 400cc and 700cc, for 26 weeks followed by endoscopic ORBERA removal. The primary study objective is to demonstrate that the incidence of device and procedure- related Serious Adverse Events (SAEs) after 26 weeks of ORBERA treatment will be no greater than 15%.

The key secondary study objective is to demonstrate that the mean percent Total Body Weight Loss (%TBWL) will be greater than 7.5% at ORBERA treatment conclusion (study week 26).

Study Population Description Male and female subjects, 22 years of age and older, with a BMI of greater than or equal to 30 kg/m2 and less than or equal to 40 kg/m2 who have failed more conservative weight- reduction alternatives, such as supervised diet, exercise, and behavioral modification programs will be enrolled into this study.
Sample Size Primary Effectiveness Endpoints: None.

Secondary Effectiveness Endpoints:

All secondary effectiveness endpoints will be evaluated at 36 months postoperatively.

Mean change in IOP

Proportion of subjects with IOP reduction greater than or equal to 20% while using the same or fewer topical ocular hypotensive medications

Proportion of subjects who are not using ocular hypotensive medication with IOP = 6mmHg and = 18 mmHg

Primary Safety Endpoints:

The rate of clinically relevant complications associated with CyPass Micro-Stent placement and stability as determined at 36 months. Specific device-related complications include:

• Failure to implant CyPass, defined as inability to successfully deploy or insert the CyPass.

• Clinically significant CyPass malposition, defined as CyPass positioning after deployment such that:

o The device is not in the supraciliary space, or

o There is a clinical sequela resulting from device position including, but not limited to:

¿ Secondary surgical intervention to modify device position (eg, repositioning, proximal end trimming or explantation)

¿ Corneal endothelial touch by device

¿ Corneal edema leading to loss of BCDVA > 2 lines at the last postoperative visit, in comparison with preoperative BCDVA

¿ Progressive endothelial cell loss (ECL), defined as ongoing reduction in endothelial cell count of 30% or

more relative to the screening endothelial cell density

(ECD) value

¿ Erosion of device through sclera

¿ Device obstruction requiring secondary surgical intervention.

Secondary Safety Endpoints:

All secondary safety endpoints will be evaluated at 36 months postoperatively.

• Rate of occurrence of sight-threatening adverse events including

o Persistent (at time of study exit) BCDVA loss of 3 or more lines compared to best BCDVA achieved during the course of study

o Endophthalmitis

o Corneal decompensation o Retinal detachment

o Severe choroidal hemorrhage or detachment o Aqueous misdirection

• The rate of ocular secondary surgical interventions (SSI)

• The rate of ocular SSIs associated with CyPass placement and stability

Other Safety Endpoints:

All other safety endpoints will be evaluated at 36 months postoperatively.

• Increase from baseline IOP of 10 mmHg or greater at any time at/after 30 days postoperative

• BCDVA loss of 2 or more lines compared to screening (Visit 0)

• BCDVA loss of 2 or more lines in comparison with best recorded BCDVA at any postoperative visit

• Device movement, defined as a change by at least 1 in the number of CyPass rings visible (e.g., from 1 ring to 2 rings or from 3 rings to 2 rings) that does not result in clinical sequelae (e.g., secondary surgical intervention to modify device position, corneal endothelial touch by device, corneal edema leading to loss of BCDVA > 2 lines at the last postoperative visit in comparison with preoperative BCDVA, progressive endothelial cell loss, erosion of device through sclera, or device obstruction requiring secondary surgical intervention), and that is not attributable to any one or

more of the following:

o variations in gonioscopic viewing angle or illumination o changes in angle anatomy due to concomitant findings

such as resolution of hyphema

o changes in anterior chamber depth

o development of focal peripheral anterior synechiae

Data Collection The primary endpoint is the incidence of device and procedure-related SAEs after 26 weeks of

ORBERA treatment. The key secondary effectiveness endpoint is the %TBWL at week 26.

Other safety endpoints are adverse events including device- and procedure-related AEs and unanticipated Serious Adverse Device Effects (USADEs).

The effectiveness endpoints are %Excess Weight Loss assuming an ideal weight of BMI=25, changes in BMI from baseline, Simplified Nutritional Appetite Questionnaire (SNAQ), and a Subject Satisfaction Survey.

Follow-up Visits and Length of Follow-up Length of follow-up includes 26 weeks of treatment, and 26 weeks of follow-up.

OSB Lead-ORBERA PAS (OPAS-001) Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 02/03/2016 05/20/2016 Overdue/Received
one year report 08/04/2016 08/03/2016 On Time
18 month report 02/02/2017 01/26/2017 On Time
two year report 08/04/2017 08/07/2017 Overdue/Received
30 month report 02/02/2018    
three year report 08/04/2018    
four year report 08/04/2019    
five year report 08/03/2020    

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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