NCT02867826

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 18, 2016

Status Verified

August 1, 2016

Enrollment Period

1 year

First QC Date

August 8, 2016

Last Update Submit

August 17, 2016

Conditions

Ampulla of Vater Intestinal-Type Adenoma

Keywords

EndoscopyAmpulla of VaterDuodenoscopy

Outcome Measures

Primary Outcomes (1)

  • Visualization rates of the ampulla of Vater

    Up to 30 minutes during gastrointestinal endoscopy

Secondary Outcomes (3)

  • 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

  • Need for additional sedation required for the Cap-assisted endoscopy.

    Up to 30 minutes during upper endoscopy

Study Arms (1)

Cap-assisted endoscopy

EXPERIMENTAL

forward-viewing endoscope with a Cap attached at the tip

Device: Cap

Interventions

CapDEVICE

Cap-assisted endoscopy

Cap-assisted endoscopy

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cap-assisted endoscopy
  • Referral to endoscopic examination of ampulla of Vater

You may not qualify if:

  • Patients with surgically modified anatomy.
  • Obstruction of the upper gastrointestinal tract.
  • Contra-indication for endoscopy.
  • Absence of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barretos Cancer Hospital

Barretos, São Paulo, 14784400, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 32646369DERIVED

MeSH Terms

Interventions

Contraceptive Devices, Female

Intervention Hierarchy (Ancestors)

Contraceptive DevicesEquipment and Supplies

Study Officials

  • Denise P Guimarães, MD, PhD

    Barretos Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise P Guimarães, MD, PhD

CONTACT

+551733216600guimaraes.dp@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 8, 2016

First Posted

August 16, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2017

Study Completion

December 1, 2017

Last Updated

August 18, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)