CryoBalloon Ablation for Treatment of Duodenal Adenomas

NCT03847636 | Active Not Recruiting DMC FDA Device

• 1 other identifier: IRB00163804
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 4

Brief Summary

This multicenter prospective non-randomized interventional study (clinical trial) that will assess the safety and efficacy of cryoballoon ablation treatment using the C2 Cryoballoon device (Pentax Medical Corporation) as an alternative primary treatment modality for sporadic and familial nonampullary nonpolypoid (flat) duodenal adenomas.

Conditions

Duodenal Adenomas; Familial Adenomatous Polyposis

Outcome Measures

Primary Outcomes (3)

• Safety of cryoBalloon ablation in treating non-ampullary non-polypoid duodenal adenomas (DAs) as assessed by the incidence of adverse events in all treated patients

  To assess incidence of treatment-related adverse events following cryoablation using the C2 cryoballoon system, defined by frequency or number of adverse events in all treated patients (per patient analysis).

  5 years

• Safety of cryoBalloon ablation in treating non-ampullary non-polypoid duodenal adenomas (DAs) as assessed by the incidence of adverse events in all treatment procedures

  To assess incidence of treatment-related adverse events following cryoablation using the C2 cryoballoon system, defined by frequency or number of adverse events in all treatment procedures (per procedure analysis).

  5 years

• Complete eradication rate of DAs

  Complete eradication (CE) rate of DAs as assessed by a combination of endoscopic and pathologic absence of adenomatous tissue in treated areas.

  1 year

Secondary Outcomes (7)

• Percent change in the treated duodenal adenoma size

  Baseline, 1 year, 2 years, 3 years, 4 years, 5 years

• Technical failure rate

  5 years

• Change in Spigelman class score

  Baseline, 1 year, 2 years, 3 years, 4 years, 5 years

• Progression rate to high grade dysplasia or duodenal cancer

  5 years

• Time to complete eradication of DAs in each patient

  5 years

Study Arms (2)

Familial Adenomatous Polyposis (FAP)

ACTIVE COMPARATOR

Individuals with duodenal adenomas (DAs) and FAP with Spigelman class 2,3 or 4, treated with cryoballoon ablation (intervention)

Device: CryoBalloon ablation

Sporadic duodenal adenomas

ACTIVE COMPARATOR

Individuals with at least 1 sporadic duodenal adenoma (DA) between 1-5 cm in maximum diameter, treated with cryoballoon ablation (intervention)

Device: CryoBalloon ablation

Interventions

CryoBalloon ablation DEVICE

Endoscopic cryoablation (cryogen is contained nitrous) using a CryoBalloon catheter to ablate up to 4 separate DA.

Familial Adenomatous Polyposis (FAP); Sporadic duodenal adenomas

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sporadic duodenal adenomas between 1 to 5 cm in widest diameter
• FAP patient with Spigelman class 2, 3 or 4 (see definition below)
• Polyp characteristics: Non-polypoid lesions Paris 2A and 2B, or
• Sessile adenomas, occupying no more than 50% circumference of duodenum, and no more than 3 duodenal folds
• Individuals must be considered high risk for surgery or endoscopic resection, due to complication risk, or declined standard therapies.

You may not qualify if:

• Suspected or proven duodenal carcinoma
• Paris 1p pedunculated, Paris 2c, or 3 lesions
• Paris 1s lesion \> 4 mm thick (estimated with closed biopsy forceps)
• Ampullary lesion or lesion involving the ampulla
• Prior failed ablative treatment with Argon Plasma Coagulation, laser, or cryotherapy
• Pre-existing esophageal, gastric, pyloric, or duodenal stenosis/stricture preventing advancement of a therapeutic endoscope during screening/baseline esophagogastroduodenoscopy (EGD.) Subjects are eligible if the stenosis/stricture is dilated to at least 15mm, but baseline treatment may need to be delayed.
• Any endoscopically-visualized abnormalities such as ulcers, masses or nodules during screening/baseline EGD within 3 cm of the treatment area.
• Subjects with nodular polyps or suspicion of invasive cancer by white light endoscopy /enhanced imaging/biopsy identified during screening/baseline EGD
• Suspicion of malignancy by abdominal or endoscopic ultrasound imaging based on malignant lymph nodes, invasion of lesion beyond mucosa.
• EMR or polypectomy \< 6 weeks prior to baseline treatment.
• Untreated invasive esophageal malignancy, including margin-positive EMR.
• Active duodenitis in treatment zone during screening/baseline EGD.
• Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist.
• Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication per standards of the institutions performing cryoablation.
• Known portal hypertension, visible esophageal, gastric, or duodenal varices, or history of varices.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Pentax Medical: collaborator

Study Sites (4)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Northwell Health

Manhasset, New York, 11030, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Adenomatous Polyposis Coli

Condition Hierarchy (Ancestors)

Adenomatous Polyps; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyposis; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Marcia I. Canto, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomized pilot study of highly selected patients

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 20, 2019
• Study Start: May 13, 2019
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 4 years
• Access Criteria: Submit request to P.I. and study team with study goal.

Locations

US (4)