Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE) (NO FEAR-BE)

  • STATUS
    Recruiting
  • End date
    Dec 17, 2024
  • participants needed
    70
  • sponsor
    University of North Carolina, Chapel Hill
Updated on 17 March 2022
cancer
carcinoma
cryotherapy
dysplasia
intestinal metaplasia
metaplasia

Summary

A multicenter, prospective, single arm, non randomized clinical trial to evaluate the safety and efficacy of the C2 CryoBalloon Focal Ablation System (CbFAS) for the treatment of persistent dysplasia or intestinal metaplasia (IM) in the tubular esophagus after 3 or more radiofrequency ablations (RFA) for dysplastic BE, or <50% eradication of Barrett's Esophagus (BE) after 2 RFA treatments.

Description

Eligibility will be determined based on historical local pathology and medical record information. Informed consent will be obtained and eligible subjects will be treated with the Cryoballoon Focal Ablation System (CbFAS) at baseline.

Subjects will return every 3 months +/- 6 weeks for repeat treatment for up to 12 months OR until complete eradication of intestinal metaplasia (CEIM) and complete eradication of dysplasia (CED) are achieved (at which point subjects enter the follow-up phase), whichever occurs first.

Treatment procedures will be performed on an outpatient basis according to the site's standards of care for anesthesia and sedation during esophagogastroduodenoscopy (EGD) procedures. EGD examinations will be performed using high definition White Light Endoscopy (WLE), plus Narrow Band Imaging (NBI) or i-SCAN to assess BE Prague Score and identify tissue landmarks and ablation zones.

A high definition endoscope will be used for all ablations performed with the CryoBalloon Focal Ablation System (CbFAS). The System will be used according to the instructions for use provided with the product and in accordance with the current standard of care for treatment of BE.

Repeat cryoablation may be performed if esophageal columnar mucosa is visible on EGD or if intervening biopsies (if a site chooses to obtain intervening biopsies as standard of care) are positive for any esophageal columnar epithelium until complete eradication of all unwanted tissue is achieved.

Intervening endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) after enrollment may be performed for nodular areas detected after baseline. EMR/ESD may be performed at the same session as the cryoablation if the EMR/ESD site is >=3cm away from the ablation target site. Cryoablation should be performed before EMR/ESD. If the EMR/ESD site is within 3cm of target treatment area, then CbFAS will be delayed for at least 6 weeks.

Residual islands of columnar mucosa of <5 mm in diameter each and <= 3 total can be treated with Argon Plasma Coagulation (APC) and/or CbFAS at the discretion of the treating physician to avoid over treatment of neo-squamous mucosa.

Stenosis requiring treatment based on the physician's discretion, which develops after enrollment, will be treated with standard of care balloon- or wire-guided dilation. Cryoablation may be performed at the same session if the dilated site is >= 3 cm from the target cryoablation site. Otherwise, cryoablation will be postponed to another visit within 1 month +/- 2 weeks.

When CbFAS treatment is received, subjects will be asked to complete assessments immediately after CbFAS treatment, and will be contacted 1 day, 7 days, and 30 days after the procedure.

If no visible BE is present during the endoscopy, then biopsies will be taken following the standard Seattle biopsy protocol (4 quadrant biopsies at 1cm intervals starting at the gastric cardia 1cm distal to the gastroesophageal junction (GEJ) (top of the gastric folds) and continuing proximally throughout the length of the original extent of BE, including any neosquamous or re-epithelialized tissue).

Biopsies will be read by local expert pathologist. If biopsies indicate CEIM and CED, then subjects will enter the 12 month follow-up phase. If biopsies do not indicate CEIM and CED, then subjects will return for additional CbFAS treatment in 3 months +/-6 weeks.

Non-responders are defined as subjects who have not achieved CEIM and CED at 12 months post baseline CbFAS treatment. Non-responders at 12 months will exit the study and continue treatment at the physician's discretion and according to standard of care at each site.

Subjects who achieve CEIM and CED within 12 months of the baseline CbFAS procedure will enter a 12 month follow-up phase. Subjects will be followed per routine care guidelines for their condition, described below:

Subjects with baseline LGD will return at 6 and 12 months from the initial CEIM and CED date for follow-up (+/-2 weeks). Subjects with baseline HGD or IMC will return at 3, 6, 9, and 12 months from initial CEIM and CED date for follow-up (+/- 2 weeks).

During follow-up procedures, high definition WLE, plus NBI or i-SCAN will be used to assess Prague score, and biopsies will be taken following the standard Seattle biopsy protocol (4 quadrant biopsies at 1cm intervals starting at the gastric cardia 1cm distal to the gastroesophageal junction (GEJ) (top of the gastric folds) and continuing proximally throughout the length of the original extent of BE, including any neosquamous or re-epithelialized tissue). Biopsies will be read by local expert pathologist.

If recurrent BE is detected during follow-up endoscopy with biopsy demonstrating compatible histology, then subjects will be exited from the study and treated at the physician's discretion.

Study participation is complete if: 1) Subject has not reached CEIM and CED at 12 month post baseline treatment; or 2) If BE or dysplasia recur after initial CEIM and CED post enrollment; or 3) After completion of the 12 month follow-up EGD with biopsies.

Details
Condition Barrett Esophagus, Intestinal Metaplasia, Esophageal Dysplasia
Treatment CryoBalloon Focal Ablation System
Clinical Study IdentifierNCT03554356
SponsorUniversity of North Carolina, Chapel Hill
Last Modified on17 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

History of BE with LGD or HGD confirmed with biopsy, or resected intramucosal cancer (IMC) with low risk of recurrence defined as EMR/ESD pathology results negative for: positive margin, >T1a stage, poorly differentiated carcinoma, and lymphovascular invasion
Prior treatment with RFA who meet either of the following criteria at the enrolling
EGD
1. History of at least 3 RFA treatments, with one or more of the following
1.1. Residual BE Prague >=C1
1.2. Residual BE >=M1
1.3. One or more islands of residual BE >1 cm in diameter
1.4. Any residual dysplasia in tubular esophagus 2.2. History of at least 2 RFA treatments and < 50% eradication of BE, as judged by estimation of the treating physician. 3. 18 or older years of age at time of consent. 4. Provides written informed consent. 5. Willing to undergo an alternative approved standard of care treatment for their
condition
\. Willing and able to comply with study requirements for follow-up. 7. No
prior history of balloon or spray cryotherapy esophageal treatment. Prior APC
is
allowable

Exclusion Criteria

Dysplasia or IM confined only to the gastric cardia (BE Prague C0M0)
Pre-existing esophageal stenosis/stricture preventing advancement of a therapeutic endoscope during screening/baseline EGD. Subjects are eligible if the stenosis/stricture is dilated to at least 15mm, but baseline treatment may need to be delayed per protocol
Symptomatic, untreated esophageal strictures
1. Follow-up endoscopy must be negative for nodular dysplasia (visually
clear of nodular dysplasia)
Residual BE Prague length measuring >C3 or >M8 after RFA treatment
Any endoscopically-visualized abnormalities such as ulcers, masses or nodules during screening/baseline EGD. Subjects with nodular dysplasia or IMC identified during screening/baseline EGD may be treated with EMR or ESD and return for baseline treatment in this study at least 6 weeks later given that
2. Patients with IMC must be at low risk for recurrence, confirmed by
EMR/ESD pathology results negative for: positive margin, >T1a stage, poorly
differentiated carcinoma, and lymphovascular invasion
EMR or ESD < 6 weeks prior to baseline treatment
Untreated invasive esophageal malignancy, including margin-positive EMR/ESD
Active reflux esophagitis grade B or higher assessed 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
Active fungal esophagitis
Inability to hold use of anti-coagulation medications or non-aspirin anti-platelet agents (APAs) for the duration recommended per ASGE guidelines for a high-risk endoscopy procedure
Known portal hypertension, visible esophageal varices, or history of esophageal varices
General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation
Pregnant or planning to become pregnant during period of study participation
Patient refuses or is unable to provide written informed consent
Prior esophageal surgery with the exception of uncomplicated nissen fundoplication
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note