Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM)

Conditions

• Colorectal Liver Metastases

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Microwave ablation — DEVICE
  Microwave ablation of colorectal liver metastases (CLM)

Study Details

To demonstrate that microwave ablation (MWA) of up to 3 hepatic metastases, each with a maximum diameter of ≤ 2.5 cm will result in a 2-year local progression free survival of at least 90%. This is a standard of care (SOC) study.

Key Dates

Start date

Jan 13, 2023

Status verified

Jan 2024

Primary completion

Nov 11, 2027

Completion

Dec 10, 2027

Study Design

Enrollment

275 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Microwave ablation with margin confirmation
  Patients who meet the eligibility criteria will undergo microwave ablation (MWA) of 1-3 colorectal cancer metastases with any FDA cleared/CE Marked Microwave Ablation System in accordance with the study site's standard-of-care (SOC) practices.

Primary Outcome Measure

Local tumor progression free survival at 24 months [ Time Frame: 24 Months ]

Central Contacts

• Research Manager
  202-367-1164
  [email protected]

Locations (5)

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