NCT07213050

Brief Summary

The anterior abdominal wall is a common site for metastatic deposits (e.g., from colorectal, ovarian, or hepatocellular carcinoma), desmoid tumors (aggressive fibromatosis), and endometriomas. Surgical resection has been the traditional standard of care. However, surgery in this region can be complex due to the proximity of vital structures, the need for large tissue resection, and high recurrence rates. Furthermore, patients often present with significant comorbidities or have recurrent disease after previous surgeries, making them poor surgical candidates While established in organs like the liver and lungs, their application specifically for abdominal wall lesions is a growing and evidence-supported field that warrants further systematic study to standardize protocols and confirm long-term outcomes. Percutaneous thermal ablation, including microwave ablation (MWA) and radiofrequency ablation (RFA), is an increasingly used minimally invasive treatment for anterior abdominal wall lesions such as metastatic tumors and benign lesions like abdominal wall endometriosis. These techniques deliver thermal energy through percutaneous probes to induce coagulative necrosis, offering an effective alternative to surgery with lower morbidity and shorter recovery times. RFA uses high-frequency electrical currents to generate heat and ablate tumors. It is well established for treating abdominal wall recurrences, particularly from colorectal cancer, with effective local control and symptom relief. Ultrasound-guided MWA has demonstrated excellent safety and efficacy for abdominal wall lesions. Studies report significant lesion volume reduction, pain relief, and low complication rates in patients with abdominal wall endometriosis and metastases. The ability to visualize the ablation zone in real-time with ultrasound enhances precision and protects adjacent structures.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Nov 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Nov 2025Dec 2026

First Submitted

Initial submission to the registry

October 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2025

Completed
24 days until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

October 8, 2025

Status Verified

October 1, 2025

Enrollment Period

1 year

First QC Date

October 1, 2025

Last Update Submit

October 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Technical Success

    complete coverage of the target lesion by the ablation zone with an adequate margin on the immediate post-procedure CT scan

    baseline

Study Arms (1)

study group

ACTIVE COMPARATOR

Patients with biopsy-proven metastases to the anterior abdominal wall (e.g.,from colorectal, breast, ovarian cancer)

Procedure: RadiofrequencyProcedure: Microwave

Interventions

achieve a target temperature of 90-110°C for 4-12 minutes, ensuring an ablative margin of at least 0.5-1.0 cm around the tumor.

study group
MicrowavePROCEDURE

Antennas will be placed under imaging guidance, and ablation will be performed for 5-10 minutes per antenna activation to achieve the desired margin.

study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Patients with biopsy-proven metastases to the anterior abdominal wall (e.g., from colorectal, breast, ovarian cancer). 2. Patients with biopsy-proven desmoid tumors (aggressive fibromatosis). 3. Patients with symptomatic abdominal wall endometriomas. 4. Lesion size ≤ 5 cm in greatest diameter. 5. Patients deemed unfit for surgery due to comorbidities, or who refuse surgical intervention. 6. Platelet count \> 50,000/µL and INR \< 1.5.

You may not qualify if:

  • \. Uncorrectable coagulopathy. 2. Lesion size \> 5 cm. 3. Unlimited diffuse peritoneal carcinomatosis. 4. Skin or bowel wall involvement with no safe percutaneous pathway for ablation (as determined on pre-procedural CT) 5. Life expectancy \< 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Microwaves

Intervention Hierarchy (Ancestors)

Radio WavesElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Nonionizing

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
residant doctor at Assiut university hospital

Study Record Dates

First Submitted

October 1, 2025

First Posted

October 8, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

October 8, 2025

Record last verified: 2025-10