Efficacy and safety of a new EMR device for early neoplasia in the Barrett's esophagus.

Completed

Conditions: 10017990
esophageal cancer
esophageal neoplasia

Registration Number: NL-OMON41826

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 11

Inclusion Criteria

Phase I
1. Age 18-80 years
2. Subject is scheduled for esophagectomy
3. Subject is willing to participate, fully understands the content of the informed consent form, and signs the informed consent form.;Phase II
1. Age 18-80 years
2. Barrett esophagus with a visible abnormality and biopsy-proven high grade dysplasia and/or early cancer
3. Lesion with a maximum size of 4 cm in longitudinal length and 50% of the circumference.
4. No suspicion of submucosal invasion, based on the macroscopic appearance and/or endosonography
5. No signs of lymph node and/or distant metastasis on endosonography and CT-scanning of the thorax and abdomen.
6. Patient is scheduled for endoscopic resection of present BE neoplasia
7. Subject is willing to participate, fully understands the content of the informed consent form, and signs the informed consent form.

Exclusion Criteria

Phase I
1. Subject has previously undergone endoscopic therapy in the intended treatment zone, including (but not limited to) cryospray therapy, laser treatment, photodynamic therapy, endoscopic mucosal resection, radiofrequency ablation or argon plasma coagulation.
2. Presence of esophageal stenosis limiting access to the intended treatment zone.
3. Scarring by other causes of the intended treatment zone.
4. Subject refuses or is not able to provide written informed consent.;Phase II
1. Subject has previously undergone endoscopic therapy in the intended treatment zone, including (but not limited to) cryospray therapy, laser treatment, photodynamic therapy, endoscopic mucosal resection, radiofrequency ablation or argon plasma coagulation.
2. Presence of esophageal stenosis limiting access to the intended treatment zone.
3. Scarring by any cause of the intended treatment zone.
4. Subject refuses or is not able to provide written informed consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Phase I<br /><br>1) Maximum diameter of the resection specimens retrieved with the Captivator<br /><br>EMR - and Duette devices.<br /><br><br /><br>Phase II<br /><br>1) Percentage of successful endoscopic resection (i.e. resection of all lesion<br /><br>delineation markings)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Phase I<br /><br>1) Difference in the number of device or procedure related complications, such<br /><br>as bleeding or perforation, experienced with the CaptivatorTM device compared<br /><br>to the DuetteTM device.<br /><br>2) Visibility of the CaptivatorTM device and the DuetteTM device (pre- and<br /><br>post-procedure).<br /><br>3) Ease of endoscopic resection<br /><br>4) Procedure time<br /><br><br /><br>Phase II<br /><br>1) Number and severity of any acute (during procedure) or early (0-48 hours)<br /><br>device or procedure related complications such as bleeding or perforation<br /><br>during endoscopic resection with the CaptivatorTM device. Complications are<br /><br>registered only if they are clinically significant.<br /><br>2) Presence of any late complications (> 48 hours) such as bleeding or<br /><br>perforation during endoscopic resection with the CaptivatorTM device.<br /><br>Complications are registered only if they are clinically significant.<br /><br>3) Procedure time</p><br>