Trial Outcomes & Findings for CryoBalloon Ablation for Treatment of Duodenal Adenomas (NCT NCT03847636)
NCT ID: NCT03847636
Last Updated: 2026-08-05
Results Overview
To assess participants with any adverse event following cryoablation using the C2 cryoballoon system (per patient analysis). This includes serious adverse events (hospitalization, emergency room visit, bleeding requiring intervention) and post-procedure upper abdominal pain, nausea and gas-bloat
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
1 year
Results posted on
2026-08-05
Participant Flow
Participant milestones
| Measure |
CryoBalloon Ablation
Individuals with duodenal adenomas (DAs) and FAP with Spigelman class 2,3 or 4, treated with cryoballoon ablation (intervention)
CryoBalloon ablation: Endoscopic cryoablation (cryogen is contained nitrous) using a CryoBalloon catheter to ablate up to 4 separate DA.
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|---|---|
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Overall Study
STARTED
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33
|
|
Overall Study
Sporadic Duodenal Adenomas
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26
|
|
Overall Study
Familial Adenomatous Polyposis
|
7
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
CryoBalloon Ablation
Individuals with duodenal adenomas (DAs) and FAP with Spigelman class 2,3 or 4, treated with cryoballoon ablation (intervention)
CryoBalloon ablation: Endoscopic cryoablation (cryogen is contained nitrous) using a CryoBalloon catheter to ablate up to 4 separate DA.
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|---|---|
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Overall Study
Withdrawal by Subject
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3
|
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Overall Study
Death
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1
|
Baseline Characteristics
CryoBalloon Ablation for Treatment of Duodenal Adenomas
Baseline characteristics by cohort
| Measure |
Individuals With Duodenal Adenomas
n=29 Participants
Individuals with duodenal adenomas (DAs) and FAP with Spigelman class 2,3 or 4, treated with cryoballoon ablation (intervention) CryoBalloon ablation: Endoscopic cryoablation (cryogen is contained nitrous) using a CryoBalloon catheter to ablate up to 4 separate DA.
OR Individuals with at least 1 sporadic duodenal adenoma (DA) between 1-5 cm in maximum diameter, treated with cryoballoon ablation (intervention) CryoBalloon ablation: Endoscopic cryoablation (cryogen is contained nitrous) using a CryoBalloon catheter to ablate up to 4 separate DA.
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|---|---|
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Age, Continuous
|
67 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
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2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
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2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
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Region of Enrollment
United States
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29 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: All participating individuals with duodenal adenomas treated in the trial.
To assess participants with any adverse event following cryoablation using the C2 cryoballoon system (per patient analysis). This includes serious adverse events (hospitalization, emergency room visit, bleeding requiring intervention) and post-procedure upper abdominal pain, nausea and gas-bloat
Outcome measures
| Measure |
Individuals With Duodenal Adenomas
n=29 Participants
Individuals with duodenal adenomas (DAs) and FAP with Spigelman class 2,3 or 4, treated with cryoballoon ablation (intervention) CryoBalloon ablation: Endoscopic cryoablation (cryogen is contained nitrous) using a CryoBalloon catheter to ablate up to 4 separate DA.
OR Individuals with at least 1 sporadic duodenal adenoma (DA) between 1-5 cm in maximum diameter, treated with cryoballoon ablation (intervention) CryoBalloon ablation: Endoscopic cryoablation (cryogen is contained nitrous) using a CryoBalloon catheter to ablate up to 4 separate DA.
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|---|---|
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Safety of CryoBalloon Ablation in Treating Non-ampullary Non-polypoid Duodenal Adenomas (DAs) as Assessed by Participants With Adverse Events
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12 Participants
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PRIMARY outcome
Timeframe: 1 yearComplete eradication (CE) rate of DAs as assessed by a combination of endoscopic and pathologic absence of adenomatous tissue in treated areas.
Outcome measures
| Measure |
Individuals With Duodenal Adenomas
n=29 Participants
Individuals with duodenal adenomas (DAs) and FAP with Spigelman class 2,3 or 4, treated with cryoballoon ablation (intervention) CryoBalloon ablation: Endoscopic cryoablation (cryogen is contained nitrous) using a CryoBalloon catheter to ablate up to 4 separate DA.
OR Individuals with at least 1 sporadic duodenal adenoma (DA) between 1-5 cm in maximum diameter, treated with cryoballoon ablation (intervention) CryoBalloon ablation: Endoscopic cryoablation (cryogen is contained nitrous) using a CryoBalloon catheter to ablate up to 4 separate DA.
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|---|---|
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Participants With Complete Eradication of DA
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23 Participants
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SECONDARY outcome
Timeframe: 1 yearTechnical failure rate is the number of patients with any treatment procedure of cryoballoon ablation that did not complete delivery of cryogen to all targeted sites.
Outcome measures
| Measure |
Individuals With Duodenal Adenomas
n=29 Participants
Individuals with duodenal adenomas (DAs) and FAP with Spigelman class 2,3 or 4, treated with cryoballoon ablation (intervention) CryoBalloon ablation: Endoscopic cryoablation (cryogen is contained nitrous) using a CryoBalloon catheter to ablate up to 4 separate DA.
OR Individuals with at least 1 sporadic duodenal adenoma (DA) between 1-5 cm in maximum diameter, treated with cryoballoon ablation (intervention) CryoBalloon ablation: Endoscopic cryoablation (cryogen is contained nitrous) using a CryoBalloon catheter to ablate up to 4 separate DA.
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|---|---|
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Technical Failure Rate
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1 Participants
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SECONDARY outcome
Timeframe: 1 yearPopulation: Participants with both baseline and 1 year biopsies collected
Progression: Patients with progression of dysplasia grade to high grade dysplasia or invasive cancer, compared to baseline biopsies, at any time during the study.
Outcome measures
| Measure |
Individuals With Duodenal Adenomas
n=29 Participants
Individuals with duodenal adenomas (DAs) and FAP with Spigelman class 2,3 or 4, treated with cryoballoon ablation (intervention) CryoBalloon ablation: Endoscopic cryoablation (cryogen is contained nitrous) using a CryoBalloon catheter to ablate up to 4 separate DA.
OR Individuals with at least 1 sporadic duodenal adenoma (DA) between 1-5 cm in maximum diameter, treated with cryoballoon ablation (intervention) CryoBalloon ablation: Endoscopic cryoablation (cryogen is contained nitrous) using a CryoBalloon catheter to ablate up to 4 separate DA.
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|---|---|
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Progression to High Grade Dysplasia or Duodenal Cancer
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0 Participants
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SECONDARY outcome
Timeframe: 1 yearNumber of patients with duodenal adenomas with completely eradication of all eligible treated DAs at 1 year, combining FAP and sporadic DA patients
Outcome measures
| Measure |
Individuals With Duodenal Adenomas
n=29 Participants
Individuals with duodenal adenomas (DAs) and FAP with Spigelman class 2,3 or 4, treated with cryoballoon ablation (intervention) CryoBalloon ablation: Endoscopic cryoablation (cryogen is contained nitrous) using a CryoBalloon catheter to ablate up to 4 separate DA.
OR Individuals with at least 1 sporadic duodenal adenoma (DA) between 1-5 cm in maximum diameter, treated with cryoballoon ablation (intervention) CryoBalloon ablation: Endoscopic cryoablation (cryogen is contained nitrous) using a CryoBalloon catheter to ablate up to 4 separate DA.
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|---|---|
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Number of Patients With Complete Eradication of All Eligible Treated DAs at 1 Year
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23 participants
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SECONDARY outcome
Timeframe: 1 yearMean number of CryoBalloon treatments for each patient to achieve complete eradication of all eligible treated DAs by one year
Outcome measures
| Measure |
Individuals With Duodenal Adenomas
n=29 Participants
Individuals with duodenal adenomas (DAs) and FAP with Spigelman class 2,3 or 4, treated with cryoballoon ablation (intervention) CryoBalloon ablation: Endoscopic cryoablation (cryogen is contained nitrous) using a CryoBalloon catheter to ablate up to 4 separate DA.
OR Individuals with at least 1 sporadic duodenal adenoma (DA) between 1-5 cm in maximum diameter, treated with cryoballoon ablation (intervention) CryoBalloon ablation: Endoscopic cryoablation (cryogen is contained nitrous) using a CryoBalloon catheter to ablate up to 4 separate DA.
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|---|---|
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Mean Number of CryoBalloon Treatments Per Patient to Achieve Complete Eradication of DAs
|
2.5 cryoballoon treatment visits
Standard Deviation 1.1
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SECONDARY outcome
Timeframe: 1 yearduodenal adenomas measuring between 1cm-5cm treated with CryoBalloon ablation.
Outcome measures
| Measure |
Individuals With Duodenal Adenomas
n=29 Participants
Individuals with duodenal adenomas (DAs) and FAP with Spigelman class 2,3 or 4, treated with cryoballoon ablation (intervention) CryoBalloon ablation: Endoscopic cryoablation (cryogen is contained nitrous) using a CryoBalloon catheter to ablate up to 4 separate DA.
OR Individuals with at least 1 sporadic duodenal adenoma (DA) between 1-5 cm in maximum diameter, treated with cryoballoon ablation (intervention) CryoBalloon ablation: Endoscopic cryoablation (cryogen is contained nitrous) using a CryoBalloon catheter to ablate up to 4 separate DA.
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|---|---|
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Eligible Duodenal Adenomas Treated
|
1 adenomas
Interval 1.0 to 7.0
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Adverse Events
Individuals With Duodenal Adenomas
Serious events: 2 serious events
Other events: 17 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Individuals With Duodenal Adenomas
n=33 participants at risk
Individuals with at least 1 sporadic duodenal adenoma (DA) between 1-5 cm in maximum diameter, treated with cryoballoon ablation (intervention) CryoBalloon ablation: Endoscopic cryoablation (cryogen is contained nitrous) using a CryoBalloon catheter to ablate up to 4 separate DA.
And Individuals with duodenal adenomas (DAs) and FAP with Spigelman class 2,3 or 4, treated with cryoballoon ablation (intervention) CryoBalloon ablation: Endoscopic cryoablation (cryogen is contained nitrous) using a CryoBalloon catheter to ablate up to 4 separate DA
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.0%
1/33 • Number of events 1 • From enrollment to last follow-up date,including after each treatment, until end of follow-up, up to 3 years
|
|
General disorders
motor vehicle accident
|
3.0%
1/33 • Number of events 1 • From enrollment to last follow-up date,including after each treatment, until end of follow-up, up to 3 years
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Other adverse events
| Measure |
Individuals With Duodenal Adenomas
n=33 participants at risk
Individuals with at least 1 sporadic duodenal adenoma (DA) between 1-5 cm in maximum diameter, treated with cryoballoon ablation (intervention) CryoBalloon ablation: Endoscopic cryoablation (cryogen is contained nitrous) using a CryoBalloon catheter to ablate up to 4 separate DA.
And Individuals with duodenal adenomas (DAs) and FAP with Spigelman class 2,3 or 4, treated with cryoballoon ablation (intervention) CryoBalloon ablation: Endoscopic cryoablation (cryogen is contained nitrous) using a CryoBalloon catheter to ablate up to 4 separate DA
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|---|---|
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Gastrointestinal disorders
Post procedure abdominal pain
|
30.3%
10/33 • Number of events 10 • From enrollment to last follow-up date,including after each treatment, until end of follow-up, up to 3 years
|
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Gastrointestinal disorders
Nausea
|
9.1%
3/33 • Number of events 3 • From enrollment to last follow-up date,including after each treatment, until end of follow-up, up to 3 years
|
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Gastrointestinal disorders
Gas bloat
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12.1%
4/33 • Number of events 4 • From enrollment to last follow-up date,including after each treatment, until end of follow-up, up to 3 years
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place