An interventional study of EndoVE in Oesophageal Cancer, Oesophageal Disease and Gastric Cancer, sponsored by Mirai Medical. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-21.
Sponsored by Mirai Medical · Not applicable, Interventional, and Treatment
This project aims to establish the safety and efficacy of treating patients with inoperable oesophageal cancer or gastric cancer, using an endoscopic electroporation system (EndoVE) to facilitate direct chemotherapy tumour absorption.
The use of electroporation has expanded over the last twenty years since its first clinically reported study in the treatment of head and neck cancer in 1991.
In electroporation short high-voltage pulses are delivered directly to the tumour which transiently permeabilises the cell membranes enabling targeted cell death and also allowing otherwise non-permeant chemotherapeutic drugs to enter the cancer cells. The parameters of a successful electroporation process are determined by the strength of the electric field and the duration of the electrical field exposure. ePORE and EndoVE deliver electroporation parameters which successfully electroporate cells in the reversible electroporation range, whilst eliminating muscular contractions. Both devices are CE marked and will be used within the definition of their intended use.
Currently over 150 sites in Europe are reported to be employing electroporation in the clinical management of head \& neck, recurrent breast, malignant melanoma, colorectal, liver metastasis, pancreatic and inoperable glioma. The standard operating procedures for electroporation and electrochemotherapy were established during the EU funded ESOPE study which established the clinical application of electroporation in combination with cisplatin or bleomycin. The EndoVE device has already been used successfully in phase I studies in patients with inoperable oesophageal and colorectal cancer. No serious adverse events were noted with positive tumour regression observed after a single treatment.
A patient recruited to the study will be requested to attend a pre-study visit where informed consent will be obtained before proceeding to review medical history and conduct a full clinical examination, full blood count, EKG and assessment of tumour volume via a CT. The procedure will happen no later than 28 days after the pre-study visit - Day 0.
On the day of the procedure, a review of any changes which occurred since the pre-study visit will be conducted. The patient will be placed under General Anaesthetic or sedated before Bleomycin will be delivered intravenously. The patient will then be treated endoscopically with the EndoVE device. The EndoVE procedure should take no longer than 30 minutes. The patient will then be transferred to the step-down ward to monitor for any adverse events before being discharged. There will be a telephone follow up after 2 days, 7 days, 4 weeks and 8 weeks. The patient will be requested to attend the clinic for a 12-week follow up for clinical review,
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's enrollment of 30 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Mirai Medical is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
The patient will be placed under General Anaesthetic or sedated before Bleomycin will be delivered intravenously. The patient will then be treated endoscopically with the EndoVE device. The EndoVE procedure should take no longer than 30 minutes. The patient will then be transferred to the step-down ward to monitor for any adverse events before being discharged. There will be a telephone follow up after 2 days, 7 days, 4 weeks and 8 weeks. The patient will be requested to attend the clinic for a 12-week follow up for clinical review.
Procedure: EndoVE
On the day of the procedure, a review of any changes which occurred since the pre-study visit will be conducted. The patient will be placed under general anaesthesia or sedated before Bleomycin will be delivered intravenously. The patient will then be treated endoscopically with the EndoVE device. The EndoVE procedure should take no longer than 30 minutes.
Also known as: ePORE
Incidence of Treatment-Emergent Adverse Events (CTCAE)
Safety evaluation will be performed via continuous assessment of safety parameters by reviewing events as they arise. The investigation will be put on hold if unacceptable safety issues are outstanding. Adverse Events (AE) and Serious Adverse Events (SAE) will be evaluated and graded according to Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: 12 weeks
Efficacy of system in palliation of dysphagia
Change in dysphagia post treatment as measured by Ogilvie Dysphagia Score
Time frame: 12 weeks
Response Evaluation Criteria in Solid Tumours (RECIST)
Following CT scan at 12 weeks, a response evaluation will be conducted and reported.
Time frame: 12 Weeks Post-Treatment
Evaluation of Patient Reported Quality of Life (EORTC QLQ30)
Change in Quality of Life Patient Reported Outcomes as measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ30
Time frame: Baseline (Day 0), Day 0 + 2 days, Day 0 + 1 week, Day 0 + 4 Weeks, Day 0 + 8 Weeks, Day 0 + 12 Weeks
Evaluation of Patient Reported Quality of Life (EORTC QLQ-OES18)
Change in Quality of Life Patient Reported Outcomes as measured by disease specific European Organisation for Research and Treatment of Cancer (EORTC) QLQ-OES18
Time frame: Baseline (Day 0), Day 0 + 2 days, Day 0 + 1 week, Day 0 + 4 Weeks, Day 0 + 8 Weeks, Day 0 + 12 Weeks
Evaluation of Pain pre and post-treatment
Change in pain experienced by the patient before and after treatment as measured by Brief Pain Inventory
Time frame: Day 0 Pre-treatment, Day 0 Post-Treatment
Plan to share: No
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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