Clinical trial · Interventional
Investigation of an Abdominal Compression Device
Analysis of an Abdominal Compression Device to Reduce Respiratory Motion of Lower Thorax and Abdominal Tumours
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is applicable to patients undergoing lower lung or abdomen stereotactic ablative body radiotherapy (SABR) treatment. The purpose of the ACE 01 study is to identify if, the volume of healthy tissue within the treatment area and therefore subsequent side effects, can be reduced by using a commercially available abdominal compression device to minimise breathing related movement. The secondary aim will be to assess patient compliance and comfort of thedevice. This will be assessed by asking the patient to complete a 'patient comfort questionnaire'. In addition the radiographers will be asked to complete a 'satisfaction questionnaire' to determine ease and reproducibility of use.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Lung | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Cancer of Stomach | Malignant Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abdominal compression belt system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study participants
- description
- Patients will be dual scanned; one with 4D-CT in free-breathing and one wearing the compression belt.Organ motion will then be quantified using Eclipse. This facilitates a direct comparison to determine the efficacy of the compression belt. Patients with reduction in organ motion will be treated wearing the abdominal compression belt. The alignment scale will be recorded to facilitate accurate placement each fraction. The belt will be inflated to a tolerable level by the patient and recorded for consistency each fraction. The position of the belt will be referenced to the anterior and lateral tattoos to ensure accurate and consistent placement each fraction.
- interventionNames
- Device: Abdominal compression belt system
Primary outcomes (1)
- measure
- To measure change in treatment volume between freebreathing and abdominal compression scans
- timeFrame
- 2 years
- description
- Organ motion will then be quantified using Eclipse. This facilitates a direct comparison to determine the efficacy of the compression belt. Patients with reduction in organ motion will be treated wearing the abdominal compression belt. The alignment scale will be recorded to facilitate accurate placement each fraction. compression belt
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * • Radiological or Histologically confirmed lower lobe lung cancer or histologically confirmed metastatic of primary cancer in abdominal organs including liver, pancreas, adrenal which meets criteria for SABR treatment. * Aged 18 years or over * Capacity to understand research proposal and give informed consent Exclusion Criteria: * Tumour sites excluding those previously defined * Rib metastases * Stoma if situated underneath belt * Patients unable to tolerate the abdominal compression belt * Patients with existing abdominal aortic aneurysm (AAA)
References
Publications (0)
Data not yet available