Clinical trial · Interventional
Irreversible Electroporation(IRE) For Unresectable Rectal Neoplasms
Irreversible Electroporation(IRE) For Unresectable Rectal Neoplasms: Phase I and Phase II Clinical Trial
NCT02425059CI-TRIAL-00053721completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Rectal Neoplasms.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irreversible electroporation (IRE) | Procedure | — | UNRESOLVED |
| NanoKnife | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IRE Group
- description
- irreversible electroporation for Unresectable Rectal Neoplasms
- interventionNames
- Procedure: Irreversible electroporation (IRE)
- Device: NanoKnife
- type
- NO_INTERVENTION
- label
- Control
- description
- The patients without treatment
Primary outcomes (1)
- measure
- Number of participants with Adverse events
- timeFrame
- 6 month
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Rectal Neoplasms diagnosed by positive biopsy or non-invasive criteria, * Not suitable for surgical resection, * Eastern Cooperative Oncology Group (ECOG) score of 0-1, * A prothrombin time ratio \> 50%, * Platelet count \> 80x10\^9/L, * Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure, * Able to comprehend and willing to sign the written informed consent form (ICF), * Have a life expectancy of at least 3 months. Exclusion Criteria: * Cardiac insufficiency, ongoing coronary artery disease or arrhythmia, * Any active implanted device (eg Pacemaker), * Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, * Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System, * Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
References
Publications (0)
Data not yet available
No reference posted for this study.