The Use of Cap-assisted Forward Viewing Endoscopy for Examination of the Ampulla of Vater

Ampulla of Vater Intestinal-Type Adenoma Clinical Trial

Official title:

The Use of Cap-assisted Forward Viewing Endoscopy for Examination of the Ampulla of Vater

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02867826
• Other study ID #: BarretosCH - 20161
• Status: Not yet recruiting
• Phase: Phase 2
• First received: August 8, 2016
• Last updated: August 17, 2016
• Start date: August 2016
• Est. completion date: December 2017

Study information

• Verified date: August 2016
• Source: Barretos Cancer Hospital
• Contact: Denise P Guimarães, MD, PhD
• Phone: +551733216600
• Email: guimaraes.dp[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the visualization rates of the ampulla of Vater using forward- viewing endoscopes with or without cap attached to the distal end in the same patient.

Description:

The complete visualization of the ampulla of Vater for the detection of ampullary neoplastic lesions is technically challenging with a forward-viewing endoscope. There are limited data in the relevant literature regarding the effectiveness of the Cap assisted forward viewing endoscope for accurate evaluation of the ampulla de Vater. Therefore, the aim of this study is to compare the visualization rates of the ampulla of Vater using forward-viewing endoscopes with or without cap attached to the distal end in the same patient.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Cap-assisted endoscopy

• Referral to endoscopic examination of ampulla of Vater

Exclusion Criteria:

• Patients with surgically modified anatomy.

• Obstruction of the upper gastrointestinal tract.

• Contra-indication for endoscopy.

• Absence of informed consent.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenoma
• Ampulla of Vater Intestinal-Type Adenoma

Intervention

Device:
• Cap
Cap-assisted endoscopy

Locations

Country	Name	City	State
Brazil	Barretos Cancer Hospital	Barretos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Barretos Cancer Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visualization rates of the ampulla of Vater		Up to 30 minutes during gastrointestinal endoscopy	No
Secondary	Rates of complications for both groups.		Up to 3 hours after upper endoscopy	Yes
Secondary	Additional time required for Cap-assisted endoscopy		Up to 30 minutes during upper endoscopy	No
Secondary	Need for additional sedation required for the Cap-assisted endoscopy.		Up to 30 minutes during upper endoscopy	No