The Use of Cap-assisted Forward Viewing Endoscopy for Exa... | NCT02867826

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

NCT02867826

Sponsor

Barretos Cancer Hospital

Status

Unknown status

Last Update Posted

Aug 18, 2016Estimated

Enrollment

120Estimated

Phase

Phase 2

Conditions

Ampulla of Vater Intestinal-Type Adenoma

Interventions

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Aug 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Aug 8, 2016

First Submission Date that Met QC Criteria

Aug 11, 2016

First Posted Date

Aug 16, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2016

Last Update Posted Date

Aug 18, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Denise Peixoto Guimarães, Principal Investigator, Barretos Cancer HospitalPrincipal Investigator

Lead Sponsor

Barretos Cancer HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cap-assisted endoscopy	Experimental	forward-viewing endoscope with a Cap attached at the tip	Device: Cap

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cap	Device	Cap-assisted endoscopy	Cap-assisted endoscopy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visualization rates of the ampulla of Vater		Up to 30 minutes during gastrointestinal endoscopy

Secondary Outcomes

Measure	Description	Time Frame
Rates of complications for both groups.		Up to 3 hours after upper endoscopy
Additional time required for Cap-assisted endoscopy		Up to 30 minutes during upper endoscopy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Denise P Guimarães, MD, PhD	Contact	+551733216600		guimaraes.dp@gmail.com

Overall Officials

Name	Affiliation	Role
Denise P Guimarães, MD, PhD	Barretos Cancer Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Barretos Cancer Hospital		Barretos	São Paulo	14784400	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32646369	Derived	Silva LC, Arruda RM, Botelho PFR, Taveira LN, Giardina KM, de Oliveira MA, Dias J, Oliveira CZ, Fava G, Guimaraes DP. Cap-assisted endoscopy increases ampulla of Vater visualization in high-risk patients. BMC Gastroenterol. 2020 Jul 9;20(1):214. doi: 10.1186/s12876-020-01361-5.

ID	Term
D003273	Contraceptive Devices
D004864	Equipment and Supplies