Trial Outcomes & Findings for Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Epithelium (NCT NCT02534233)

Results Overview

Evaluate by patient questionnaire for pain on an 11-point scale. The 11-point Likert scale represents a range of discomfort or pain from 0 (no pain) to 10 (extreme pain), which individuals indicate their level of discomfort or pain. Higher score more discomfort. Each subject is evaluated for post-treatment pain after each cryoablation session. Subjects may have a different number of treatment sessions depending on the extent of disease.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

58 participants

Primary outcome timeframe

1 day post treatment (day 2), 1 week post treatment (day 8), and 1 month (day 31)

Results posted on

2025-08-01

Participant Flow

Individuals who are clinical patients of the Principal Investigator or Co-investigators will be identified as eligible by prior pathology proven biopsies with either Barrett's esophagus with dysplasia or esophageal squamous cell dysplasia. Recruitment will occur primarily in the outpatient GI clinic but can also be a phone contact and follow-up study consent for review with informed consent call.

5 subjects were determined ineligible with index endoscopy finding exclusions, strictures restricting therapeutic scope or invasive disease.

Participant milestones

Participant milestones
Measure	CryoBalloon Ablation Patients having ablation of dysplastic tissue in esophagus. CryoBalloon: Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter
Overall Study STARTED	53
Overall Study 12 Month	51
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	CryoBalloon Ablation Patients having ablation of dysplastic tissue in esophagus. CryoBalloon: Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter
Overall Study 2 participants with protocol deviations didn't complete	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CryoBalloon Ablation n=53 Participants Patients having ablation of dysplastic tissue in esophagus. CryoBalloon: Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter
Age, Categorical <=18 years	0 Participants n=53 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=53 Participants
Age, Categorical >=65 years	39 Participants n=53 Participants
Age, Continuous	64.7 years STANDARD_DEVIATION 1 • n=53 Participants
Sex: Female, Male Female	8 Participants n=53 Participants
Sex: Female, Male Male	45 Participants n=53 Participants
Region of Enrollment United States	53 Participants n=53 Participants
Likert 11 Point Pain Score (0 no pain-10 worst)	0 units on a scale n=53 Participants

PRIMARY outcome

Timeframe: 12 months

Population: 51 assessable adult patients with data collected at 12 months

Evaluate histopathology of esophageal tissue for absence of Barrett's esophagus or squamous dysplasia after cryoablation treatments (assess for complete eradication of dysplasia).

Outcome measures

Outcome measures
Measure	CryoBalloon Ablation n=51 Participants Patients having ablation of dysplastic tissue in esophagus. CryoBalloon: Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter
Number of Participants With Complete Eradication of Esophageal Dysplasia	51 Participants

PRIMARY outcome

Timeframe: 1 day post treatment (day 2), 1 week post treatment (day 8), and 1 month (day 31)

Evaluate by patient questionnaire for pain on an 11-point scale. The 11-point Likert scale represents a range of discomfort or pain from 0 (no pain) to 10 (extreme pain), which individuals indicate their level of discomfort or pain. Higher score more discomfort. Each subject is evaluated for post-treatment pain after each cryoablation session. Subjects may have a different number of treatment sessions depending on the extent of disease.

Outcome measures

Outcome measures
Measure	CryoBalloon Ablation n=51 Participants Patients having ablation of dysplastic tissue in esophagus. CryoBalloon: Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter
Treatment-related Adverse Events Assessed by Pain Scale Likert Pain score at 1 day post each cryoablation treatment	1 units on a scale Interval 0.0 to 3.0
Treatment-related Adverse Events Assessed by Pain Scale Likert Pain score at 1 week post each cryoablation treatment	0 units on a scale Interval 0.0 to 3.0
Treatment-related Adverse Events Assessed by Pain Scale Likert Pain score at 1 month post each (day 31 post each cryoablation treatment	0 units on a scale Interval 0.0 to 3.0

PRIMARY outcome

Timeframe: Up to 12 months

Number of patients with esophageal strictures requiring dilation. Patients reporting dysphagia with solid food, with balloon dilations from index visit to 12 months.

Outcome measures

Outcome measures
Measure	CryoBalloon Ablation n=51 Participants Patients having ablation of dysplastic tissue in esophagus. CryoBalloon: Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter
Treatment-related Adverse Events Assessed by Stricture Rate	6 Participants

SECONDARY outcome

Timeframe: 12 months

Population: 41 of the 51 evaluable subjects had Barrett's esophagus (intestinal metaplasia) data collected at 12 months; this outcome measure does not apply to subjects with esophageal squamous dyplasia.

Evaluate histopathology of esophageal tissue for absence of Barrett's esophagus (intestinal metaplasia) after cryoablation

Outcome measures

Outcome measures
Measure	CryoBalloon Ablation n=41 Participants Patients having ablation of dysplastic tissue in esophagus. CryoBalloon: Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter
Number of Participants With Complete Eradication of Intestinal Metaplasia	35 Participants

Adverse Events

CryoBalloon Ablation

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CryoBalloon Ablation n=53 participants at risk Patients having ablation of dysplastic tissue in esophagus. CryoBalloon: Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter
Gastrointestinal disorders GI Bleeding	1.9% 1/53 • Number of events 1 • Post ablation treatment assessment day 1, 7 days, 30 days, and follow up endoscopies up to 12 months pain (0-10 Likert pain scale,) pain requiring narcotics, dysphagia (0-4 dysphagia score), bleeding, esophageal strictures requiring dilation.
Gastrointestinal disorders post cryoablation treatment pain requiring narcotics	3.8% 2/53 • Number of events 2 • Post ablation treatment assessment day 1, 7 days, 30 days, and follow up endoscopies up to 12 months pain (0-10 Likert pain scale,) pain requiring narcotics, dysphagia (0-4 dysphagia score), bleeding, esophageal strictures requiring dilation.
Gastrointestinal disorders Esophageal stricture requiring dilation	11.3% 6/53 • Number of events 6 • Post ablation treatment assessment day 1, 7 days, 30 days, and follow up endoscopies up to 12 months pain (0-10 Likert pain scale,) pain requiring narcotics, dysphagia (0-4 dysphagia score), bleeding, esophageal strictures requiring dilation.

Other adverse events

Adverse event data not reported

Additional Information

Dr Marcia Canto, Director of Clinical Research

Johns Hopkins Hospital

Phone: 443-287-8083

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place