Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06317727
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-02-22
Brief Title:
PULSed Field ablAtion of coloRectal Polyps
Sponsor:
Kings College Hospital NHS Trust
Organization:
Kings College Hospital NHS Trust
Study Overview
Official Title:
Pulsed Field Ablation of Colorectal Polyps
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PULSAR
Brief Summary:
The goal of this observational study is to learn about the role of electroporation the use of small electric pulses applied to tissue in the treatment ablation of colorectal polyps The main questions to answer in this pilot phase of the study are
1 The safety of pulsed field ablation PFA for the removal of colorectal polyps
2 The efficacy and feasibility of PFA in the treatment of colorectal polyps using metrics such as treatment coverage treatment time post treatment fibrosis post treatment recurrence and patient satisfaction
1 The safety of pulsed field ablation PFA for the removal of colorectal polyps
2 The efficacy and feasibility of PFA in the treatment of colorectal polyps using metrics such as treatment coverage treatment time post treatment fibrosis post treatment recurrence and patient satisfaction
Detailed Description:
Colorectal cancer is the commonest cancer of the digestive tract the second commonest cause of cancer deaths in the western hemisphere and the third commonest cancer in the United Kingdom Most bowel cancers arise from precancerous growths called polyps Prompt and effective treatment of these polyps can potentially prevent or cure bowel cancer at its earliest stages Kings College Hospital runs a special service dedicated to treating these lesions called the Special Polyps and Early Colorectal Cancer Service SPECCS using a variety of methods These techniques usually involve removing the polyps through endoscopic resection Other options include laparoscopic surgery robotic surgery and rarely open surgery These modalities of treatments come with a number of risks are highly invasive require extensive skill and also have a long waiting list
Endoscopic ablation with electroporation offers the potential of treating colorectal polyps in an easier faster and less invasive manner Electroporation uses small high frequency electric pulses applied on the surface of tissues to temporarily open up pores in the outer wall of these cells These pores disrupts the structure of the abnormal cells and cause cell death via apoptosis This approach has been used to treat frail patients with advanced colored cancer who cannot undergo more aggressive forms of treatment and it is postulated that this technology also has the ability to deal with colorectal polyps This study is a pilot research involving a small number of patients with colorectal polyps who will be treated with electroporation given during colonoscopy
Patients who participate in this study will be treated using endoscopic electroporation with the intent of ablating NICE Narrow Band Imaging International Colorectal Endoscopic classification Type 1 or Type 2 colorectal polyps The treatment will typically be carried out under sedation Small risks for this procedure include complications such as bleeding intestinal perforation infection and an adverse reaction to the anaesthetic medication Patients who have been treated with electroporation have also reported the following symptoms following treatment pyrexia obstipation diarrhea pyrexia nausea headaches and joint pain Patients will be required to return for the first follow-up visit approximately 6 weeks after the initial treatment at which time they will need to have a colonoscopy If there is evidence that the initial treatment has not removed 100 of the polyp an additional treatment will be offered or the polyp will be removed by Endoscopic Mucosal Resection EMR which is the standard treatment for this indication This decision will be taken by the patients primary physician Patients who have an additional treatment will return approximately 12 weeks after the initial treatment for another colonoscopy that falls outside of standard of care protocol All other visits fall under the standard care timelines Patients who have successfully been treated with endoscopic ablation will undergo a biopsy at either the first or second follow up visit to exclude residual disease This will be performed when the patient is under sedation
Clinical review and colonoscopy will be repeated at 6weeks 6months and 5years from initial contact to assess the effectiveness on the polyp and the safety of the patient
Endoscopic ablation with electroporation offers the potential of treating colorectal polyps in an easier faster and less invasive manner Electroporation uses small high frequency electric pulses applied on the surface of tissues to temporarily open up pores in the outer wall of these cells These pores disrupts the structure of the abnormal cells and cause cell death via apoptosis This approach has been used to treat frail patients with advanced colored cancer who cannot undergo more aggressive forms of treatment and it is postulated that this technology also has the ability to deal with colorectal polyps This study is a pilot research involving a small number of patients with colorectal polyps who will be treated with electroporation given during colonoscopy
Patients who participate in this study will be treated using endoscopic electroporation with the intent of ablating NICE Narrow Band Imaging International Colorectal Endoscopic classification Type 1 or Type 2 colorectal polyps The treatment will typically be carried out under sedation Small risks for this procedure include complications such as bleeding intestinal perforation infection and an adverse reaction to the anaesthetic medication Patients who have been treated with electroporation have also reported the following symptoms following treatment pyrexia obstipation diarrhea pyrexia nausea headaches and joint pain Patients will be required to return for the first follow-up visit approximately 6 weeks after the initial treatment at which time they will need to have a colonoscopy If there is evidence that the initial treatment has not removed 100 of the polyp an additional treatment will be offered or the polyp will be removed by Endoscopic Mucosal Resection EMR which is the standard treatment for this indication This decision will be taken by the patients primary physician Patients who have an additional treatment will return approximately 12 weeks after the initial treatment for another colonoscopy that falls outside of standard of care protocol All other visits fall under the standard care timelines Patients who have successfully been treated with endoscopic ablation will undergo a biopsy at either the first or second follow up visit to exclude residual disease This will be performed when the patient is under sedation
Clinical review and colonoscopy will be repeated at 6weeks 6months and 5years from initial contact to assess the effectiveness on the polyp and the safety of the patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None