Abdominal aBscess Catheter Sclerotherapy (ABCS)

NCT06906029 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: IRB-300014540000548435
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, two arm phase I/II clinical trial exploring the use of chemical sclerosants (ethanol and povidone iodine) in decreasing the time needed for catheter drainage for patients with non-fistulous intraabdominal abscesses. The target study sample size is 60 patients, 30 in each arm and abscess size is to be a minimum of 3cm in all 3 dimensions. The primary outcomes of interest will be tolerability and need for catheter reinsertion by one week post intervention.

Conditions

Abdominal Abscess

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Iodine Arm

ACTIVE COMPARATOR

Catheter-based drainage and povidone iodine sclerotherapy of non-fistulous intraabdominal abscesses.

Drug: Catheter Sclerotherapy

Ethanol Arm

ACTIVE COMPARATOR

Catheter-based drainage and ethanol sclerotherapy of non-fistulous intraabdominal abscesses.

Drug: Catheter Sclerotherapy

Interventions

Catheter Sclerotherapy DRUG

Place 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.

Ethanol Arm; Iodine Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 all study procedures and availability for the duration of the study

You may not qualify if:

• Pregnancy or lactation
• Known allergic reactions to povidone iodine or ethanol
• Hemodynamic instability

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Argon Medical Devices: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Abdominal Abscess

Condition Hierarchy (Ancestors)

Abscess; Suppuration; Infections

Study Officials

• Junaid Raja, MD, MSPH, FACP

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evan Husdon, MS

CONTACT

205-934-6499; evanhudson@uabmc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Division of Interventional Radiology

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 2, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)