C2 Esophageal Squamous Epithelium Dysplasia

• Sponsor: Pentax Medical (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05349240
• Collaborator: (none)
• Enrollment: 129
• Locations: 4
• Arm: 1
• Anticipated Duration (Months): 18.5
• Patients Per Site: 32.3
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

This study will evaluate the efficacy and safety of C2 CryoBalloonTM Ablation System for the cryoablation of dysplastic squamous tissue in patients with moderate to severe esophageal squamous epithelium dysplasia.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Squamous Epithelium Dysplasia	Device: C2 CryoBalloonTM Ablation System.	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 129 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of C2 CryoBalloonTM Ablation System in Patients With Esophageal Squamous Epithelium Dysplasia
• Anticipated Study Start Date: Jun 15, 2022
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Intervention All subjects will receive treatment with the study device.	Device: C2 CryoBalloonTM Ablation System.; Cryoablation is used to ablate the tissue under the cryogenic condition. The device is mainly used to destroy the unhealthy tissues.

Outcome Measures

Primary Outcome Measures

1. Percentage of subjects who have complete remission of all the moderate to severe dysplasia in initial treatment area [12 Month]

   Percentage of complete remission at 12 months

Secondary Outcome Measures

1. 1) Percentage of subjects who have complete remission of all the moderate to severe dysplasia in initial by one time of treatment [12 Month]

   Percentage of patients who need only 1 treatment

2. 2) Percentage of patients with complete remission of all the moderate to severe dysplasia in initial treatment area [12 Month]

Other Outcome Measures

1. Safety Endpoints [12 Months]

   Frequency of adverse events and frequency of device related adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male or female of 18 to 80 years old (including 18 and 80 years old).

2. At least one unstained lesion (USL) in the esophagus upon high resolution upper gastrointestinal endoscopy with Lugol's staining. Flat (Paris type 0-IIb) USL, with the total area of one or more USLs having a maximum longitudinal size of 6 cm and covering a maximum of one-half of the esophageal circumference.

3. Patients with one or more biopsy confirmed esophageal squamous epithelium dysplasia areas within 6 months prior to enrollment, and the pathological diagnosis is moderate to severe esophageal squamous epithelium dysplasia.

4. No potential of lymph node metastasis by preoperative comprehensive evaluation.

Exclusion Criteria:

Inclusion criteria:

1. Male or female of 18 to 80 years old (including 18 and 80 years old).

2. At least one unstained lesion (USL) in the esophagus upon high resolution upper gastrointestinal endoscopy with Lugol's staining. Flat (Paris type 0-IIb) USL, with the total area of one or more USLs having a maximum longitudinal size of 6 cm and covering a maximum of one-half of the esophageal circumference.

3. Patients with one or more biopsy confirmed esophageal squamous epithelium dysplasia areas within 6 months prior to enrollment, and the pathological diagnosis is moderate to severe esophageal squamous epithelium dysplasia.

4. No potential of lymph node metastasis by preoperative comprehensive evaluation.

5. The patients are self volunteered to participate in the trial and will sign an informed consent form prior to enroll.

Exclusion criteria:

1. Females who are pregnant, lactating or plan to get pregnant during the study.

2. Known hypersensitivity to iodine.

3. Lesions within the target area such as: obvious ulcer; varices at risk of bleeding; active inflammation due to esophageal reflux into the treatment area; lesions view being not flat, or containing unfavourable unstained lesions (USLs) outside the designated treatment areas.

4. Esophageal stenosis preventing the passage of the endoscope to the treatment area. Esophageal stenosis or stricture preventing advancement of a therapeutic endoscope within 4 cm of the treatment area.

5. Having previously received Heller surgery: any previous ablative esophageal surgery (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, laser treatment) or any previous esophageal surgery except for anti-reflux surgery.

6. Suffering from any cancer in the past 5 years.

7. Severe bleeding potential; patients on anti-coagulative therapy or stopping using anti-coagulative drugs for less than 7 days before enrollment or with impaired coagulation.

1. Patients with unstable vital signs 10) Anti-human immunodeficiency virus (HIV) antibody positive, both syphilis serology Treponema pallidum-specific antibody test and rapid plasma reagin positive.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Hospital Chinese Academy of Medical Sciences	Beijing		China
2	The First Bethune Hospital of Jilin University	Changchun		China
3	Changzhi People's Hospital	Changzhi		China
4	The Second Hospital of Hebei Medical University	Shijiazhuang		China

Sponsors and Collaborators

• Pentax Medical

Investigators

• Principal Investigator: Guiqi Wang, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pentax Medical
• ClinicalTrials.gov Identifier: NCT05349240
• Other Study ID Numbers: CBAS_DIII_19001
• First Posted: Apr 27, 2022
• Last Update Posted: Apr 27, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Hyperplasia

Study Results

No Results Posted as of Apr 27, 2022