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Patients with MGIN, HGIN or flat-type early SCCA of the esophagus will be treated on 3 month intervals with Radiofrequency Ablation (RFA) until complete eradication (CR: no MGIN or worse in the biopsies) will be achieved. All patients will undergo an endoscopy at 12 months after baseline, and the patients with CR will undergo annual endoscopy with biopsies for 5 years.
A patient population with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, in lesions measuring 3 to 12cm in length, will be treated with radiofrequency ablation (RFA) using the HALO ablation system. Additional RFA sessions will be performed on 3 month intervals until complete response (CR; no MGIN or worse in biopsies) will be achieved. All patients will then undergo an endoscopy at 12 months after baseline. Patients with CR at 12 months will be followed-up for 5 years with annual endoscopy and biopsies, and additional treatment if necessary. Patients with no CR at 12 months are considered failures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency ablation | Experimental | To study the safety and effectiveness of radiofrequency ablation (RFA) using the HALO ablation system in completely eradicating the diseased epithelium in patients with ESCN |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency Ablation | Device | Patients with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, are treated with radiofrequency ablation, with repeat endoscopy and follow-up treatment at 3 month intervals. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response | The percentage of subjects demonstrating complete response (CR) defined as complete histological clearance of MGIN, HGIN and SCCA in the treatment area at 12 months after the initial ablation procedure | 12 Month |
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Inclusion Criteria:
Subject is 18-80 years of age, inclusive
Subject meets at least one of the following inclusion criteria:
On endoscopic examination, subject has at least one USL that measures at least 3 cm in at least one dimension and has MGIN or worse (MGIN+) on biopsy
The maximum allowable linear length of "USL-bearing esophagus" is 12 cm
Baseline EUS (all patients) shows no exclusionary findings for the trial
CT scan of chest and upper third of the abdomen (all HGIN and SCCA patients) shows no exclusionary findings for the trial
Subject is not pregnant nor has plans to become pregnant in the ensuing 12 months (confirmation of non-pregnant status in women of child-bearing age and ability required with urine or blood test)
Subject is eligible for treatment and follow-up endoscopy and biopsy as required by the protocol
The subject is willing to provide written, informed consent to participate in this clinical study and understands the responsibilities of trial participation
Exclusion Criteria:
the Eligibility CRF.
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| Name | Affiliation | Role |
|---|---|---|
| Guiqi Wang, MD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Beijing | 100021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25668428 | Result | He S, Bergman J, Zhang Y, Weusten B, Xue L, Qin X, Dou L, Liu Y, Fleischer D, Lu N, Dawsey SM, Wang GQ. Endoscopic radiofrequency ablation for early esophageal squamous cell neoplasia: report of safety and effectiveness from a large prospective trial. Endoscopy. 2015 May;47(5):398-408. doi: 10.1055/s-0034-1391285. Epub 2015 Feb 10. | |
| 21839994 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiofrequency Ablation | To study the safety and effectiveness of radiofrequency ablation (RFA) using the HALO ablation system in completely eradicating the diseased epithelium in patients with ESCN Radiofrequency Ablation: Patients with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, are treated with radiofrequency ablation, with repeat endoscopy and follow-up treatment at 3 month intervals. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiofrequency Ablation | To study the safety and effectiveness of radiofrequency ablation (RFA) using the HALO ablation system in completely eradicating the diseased epithelium in patients with ESCN Radiofrequency Ablation: Patients with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, are treated with radiofrequency ablation, with repeat endoscopy and follow-up treatment at 3 month intervals. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Response | The percentage of subjects demonstrating complete response (CR) defined as complete histological clearance of MGIN, HGIN and SCCA in the treatment area at 12 months after the initial ablation procedure | Posted | Count of Participants | Participants | 12 Month |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Radiofrequency Ablation | To study the safety and effectiveness of radiofrequency ablation (RFA) using the HALO ablation system in completely eradicating the diseased epithelium in patients with ESCN Radiofrequency Ablation: Patients with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, are treated with radiofrequency ablation, with repeat endoscopy and follow-up treatment at 3 month intervals. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mucosal Lacerations | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director of Clinical Affairs | Medtronic MITG-RGI | 303-581-7064 | Tumordirectedtherapiesclinical@Medtronic.com |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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|
|
| Bergman JJ, Zhang YM, He S, Weusten B, Xue L, Fleischer DE, Lu N, Dawsey SM, Wang GQ. Outcomes from a prospective trial of endoscopic radiofrequency ablation of early squamous cell neoplasia of the esophagus. Gastrointest Endosc. 2011 Dec;74(6):1181-90. doi: 10.1016/j.gie.2011.05.024. Epub 2011 Aug 15. |
| 30905354 | Derived | Yu X, van Munster SN, Zhang Y, Xue L, Fleischer DE, Weusten BLAM, Lu N, Dawsey SSM, Bergman JJGHM, Wang G. Durability of radiofrequency ablation for treatment of esophageal squamous cell neoplasia: 5-year follow-up of a treated cohort in China. Gastrointest Endosc. 2019 Apr;89(4):736-748.e2. doi: 10.1016/j.gie.2018.10.030. Epub 2018 Oct 26. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | (kg/m^2) |
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| Current Use of Tabacco | Count of Participants | Participants |
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| Current Use of Alcohol | Count of Participants | Participants |
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| History of Cancer | Count of Participants | Participants |
|
| Grade of esophageal neoplasia at study entry | Count of Participants | Participants |
|
| Length of unstained lesions | Mean | Standard Deviation | CM |
|
| Length of treatment area | Mean | Standard Deviation | CM |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 96 |
| 0 |
| 96 |
| 25 |
| 96 |
| Mucosal Bleb | Surgical and medical procedures | Systematic Assessment |
|
| Stricture | Surgical and medical procedures | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |