The aim of the current study is to assess the feasibility, safety and efficacy of the Steam ablation System for eradication of small BE areas
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety:
Safety will be assessed by the incidence and severity of any complications that
are associated with the vapor ablation throughout the follow-up period.
Included in this assessment will be the proportion of subjects with any of the
following outcomes from initiations of vapor ablation therapy and completion of
the 6-8 week evaluation: (1) death, or (2) medical morbidity associated with
the device and/or vapor ablation, including perforation, hemorrhage, scarring
or stricture formation.
Efficacy:
The primary efficacy endpoint is the complete regression of intestinal
metaplasia with each vapor ablation dose at 6-8 weeks follow-up as ascertained
by endoscopic visualization and histopathologic evaluation.
Secondary outcome
Other evaluations include, but are not limited to the following:
* Deployment ease/scope compatibility.
* Device malfunctions.
* Time of catheter deployment.
* Adverse events.
* Stricture formation at 6 to 8 weeks.
* Patient Pain.
* Histological evaluation of treatment zone at 6 to 8 weeks for presence of
residual Barrett*s Esophagus.
* Histologic evaluation of direct ablation effects in the resected lesion in
group 2.
Background summary
Barrett's esophagus (BE) is a premalignant disease that may cause esophageal
adenocarcinoma. This particular cancer is one of the most rapidly increasing
and deadliest cancers in the Western world. Patients with BE are up to 40 times
more at risk of developing esophageal adenocaricinoma than individuals without
BE. Once diagnosed with BE, patients enter a life-long surveillance programme
in which upper gastrointestinal endoscopies with biopsies are performed to
survey the progression of Barrett's tissue to cancer.
The presence of dysplasia or cancer in the BE, is a direct indication for
treatment. The most important first step in the treatment of BE is removal of
any visible lesion with endoscopic resection. The residual, flat BE segment
should then be eradicated with ablation therapy. During the last 20 years, many
different technologies have been evaluated for the treatment of BE.
Radiofrequency Ablation (RFA) is currently the standard of care, since a large
amount of studies has shown that the technique is safe and effective. However,
the technique is associated with some important limitatins. The device is
rather large, and therefore it cannot be used 'through-the-scope', but an
additional removal and introduction of the entire endoscope is always required.
This results in a time consuming and technically complicated procedure.
Furthermore, the large device cannot be used in patients with an esophageal
stenosis, which is a common complication after prior treatment. Moreover, large
generators are required and capital investment is necessary. There is need for
an easier, safe and effective, through-the-scope ablation system for the
treatment of BE.
The Aqua Medical Steam Ablation System (AFVAS) is subject of the current studie
and fullfills these criteria. The device is small and hand-held and van be
advanced through the working channel of an endoscope. The device can be used in
patients with a stenosis. Prior animal studies showed that a dosing of 3 to 5
seconds results in ablation effects comparable to radiofrequency ablation.
Study objective
The aim of the current study is to assess the feasibility, safety and efficacy
of the Steam ablation System for eradication of small BE areas
Study design
Prospective, single-centre, single-arm clinical intervention study
Intervention
The AFVAS consists of the following components:
- Radio-frequency Vapor Generator: A software-controlled RF generator operated
through a graphical user interface (GUI) and incorporates a syringe pump that
delivers saline to the catheter.
- Disposable, Sterile, Single-Use Catheter: Single-use catheter available in
various lengths ranging from 100cm to 170cm. It includes an integrated cable
for attachment to the generator and a luer-connector that facilitates
connection to the saline delivery tubing. The catheter is available with an
integrated hood or can be used with any commercially available distal
attachment tip to contain the vapor for ablation.
- Saline Delivery Tubing and Syringe: A saline delivery tubing and syringe
(60cc) that provide a means of delivering saline to the catheter during
treatment.
Patients will be treated with 4 focal applicaties of approximately 2 squared
centimeters per application. Patients with a visible lesion will be treated
with 1 to 2 applications, based on the length of the lesion.
Study burden and risks
Patients in the current study have an indication for treatment, and normally
they would have had an upper gastrointestinal endoscopy with the standard
treatment. During this endoscopy, we now treat small BE areas with Steam
Ablation. The follow-up endoscopy will be scheduled earlier, for careful
imaging and biopsies. This is identical to standard care. From that moment,
patients will be treated with the standard treatment.
It is hard to evaluate whether patients will have to undergo an extra endoscopy
for the purpose of this study, since multiple treatment endoscopies are
required for the standard treatment in any case. The technique is tested safe
in animal studies, and the dosing for the current study shows comparable
effects to the standard treatment in the animal lab. We treat only very limited
areas (2 squared centimeters), which will be associated with a low risk for
complications.
After the procedure, patients will be called 3 times to assess how they are
doing and to evaluate adverse events. Patients will be asked to rate their pain
scores in an online diary during the first 14 days after treatment. Apart from
that, follow-up care is identical to standard care.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
a. Subject is between 22 * 85 years of age.
b. Subject should have Barrett esophagus, with either:
I. Barrett esophagus, circumferential extent * 2 cm or tongues * 3 cm,
with an indication for ablation therapy, either:
i. Flat low grade dysplasia (LGD)
ii. Flat high grade dysplasia (HGD)
iii. Residual Barrett after removal of visible lesions, containing any
grade of dysplasia, or early adenocarcinoma
amendable for endoscopic treatment (mucosal or superficial
submucosal disease, with well to moderately
differentiation and without lymphovascular invasion).
II. Barrett esophagus with a visible lesion with a type 0-IIa, -IIb or -IIc
component, requiring endoscopic resection
c. Hiatal Hernia < 10cm
d. Subject has signed the informed consent form and is able to adhere to study
visit schedule.
Exclusion criteria
a. Subject has any condition that in the opinion of the PI preclude enrollment
into the trial.
b. Subject has had a prior RF or cryoablation procedure
c. Subject has predictors for poor regression after ablation therapy, i.e. one
of the following:
* In case of prior ER: regeneration of the ER scar with Barrett*s mucosa, OR
* Active reflux esophagitis grade C or D
* Esophageal narrowing pre-treatment with an estimated diameter <20mm
* Absence of squamous islands in the BE
d. Subject has any significant multisystem diseases.
e. Subject has a body mass index (BMI) greater than 40 kg/m2.
f. Subject has a hiatal hernia > 10cm
g. Subject has known moderate/severe gastroparesis
h. Subject is currently enrolled in other potentially confounding research.
i. Subject has an esophageal stenosis preventing the passage of an endoscope
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | 29503 (kandidaattrial nummer NTR) |
| CCMO | NL67326.018.18 |
| OMON | NL-OMON28412 |