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Catheter Sclerotherapy

Phase 1

Abdominal Abscess | Small molecule | Other |Merit Medical Systems, Inc.|Last Updated: Jul 11, 2025

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
RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06906029Abdominal aBscess Catheter Sclerotherapy (ABCS)PHASE1 NOT YET_RECRUITING 60Jul 1, 2026Jul 1, 2028Jul 11, 20251 United States
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Study Endpoints
Primary Endpoints
Percentage of patients with VAS pain exceeding 7 following the catheter sclerotherapy or SIR grade 3 or higher complication.
Baseline to day 7 plus or minus 7 days
Percentage of patients that will require reintervention for the same intrabdominal abscess within one week.
Baseline to day 7 plus or minus 7 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Iodine ArmACTIVE_COMPARATORCatheter-based drainage and povidone iodine sclerotherapy of non-fistulous intraabdominal abscesses.
Ethanol ArmACTIVE_COMPARATORCatheter-based drainage and ethanol sclerotherapy of non-fistulous intraabdominal abscesses.
Interventions
NameTypeDescription
Catheter SclerotherapyDRUGPlace a drainage catheter of minimum 14F in caliber and obtain an antimicrobial sample. Saline lavage will be performed by irrigating the abscess and aspirating the contents until the character of the instilled and aspirated fluid are similar. Following this step the cavity will be drained in full and a volume of approximately equal to the cavity of povidone iodine or ethanol will be instilled through the catheter with the catheter turned off to drainage. After approximately two minutes the drain will be opened to gravity and two minutes of additional time will be allotted to drain any excess povidone iodine or ethanol. The catheter will then be removed, and the site dressed with gauze and film dressing. The patient will then be followed clinically in the hospital for at least 48 hours and by phone check in for 7 days.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female, aged over 18years * Cross-sectional imaging (CT, US, MRI) showing an intraabdominal abscess measuring at last 3cm in each dimension without fistula to the bowel or skin. * Provision of signed and dated informed consent form * Stated willingness to comply with a...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06906029studyFirstPostDate: changed