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RS2

Phase 1

Obesity | Unknown | Metabolic |Becton, Dickinson and Company|Last Updated: Jan 11, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00679848Transoral Gastric Volume Reduction as an Intervention for Weight ManagementPHASE1 COMPLETED 18May 1, 2008Nov 1, 2010Jan 11, 20172 United States
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Study Endpoints
Primary Endpoints
Weight Loss
24 Months
Secondary Endpoints
Technical success of test procedure.
24 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALTransoral Suturing
Interventions
NameTypeDescription
RS2 (RESTORe Suturing System)DEVICESuturing in stomach
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Male, Female; ages \>18yrs - £ 60 yrs * BMI 30-45 kg/m2 * History of obesity for 5 yrs; attempts at weight control ineffective * Weight stable * Willing to comply with study requirements * Agrees to not have any additional weight loss surgery, reconstructive surgery or liposuc...

Countries:United States
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