NCT02877797

Brief Summary

Aim of the present study is the evaluation of the diagnostic value of a cap assisted upper GI-endoscopy compared to a standard upper GI-endoscopy regarding the visualisation and evaluation of the papilla duodeni major.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 29, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
Last Updated

August 24, 2016

Status Verified

August 1, 2016

Enrollment Period

3 months

First QC Date

February 29, 2016

Last Update Submit

August 19, 2016

Conditions

Visualisation and Evaluation of Ampulla of Vater

Outcome Measures

Primary Outcomes (1)

  • Rate of complete visualisation of papilla duodeni major

    visualisation: none, incomplete, complete

    120 seconds

Secondary Outcomes (3)

  • Diagnostic yield in the upper GI-tract

    up to 10 minutes

  • time of investigation

    up to 10 minutes

  • complication rate

    up to one week

Study Arms (2)

standard Esophagogastroduodenoscopy

NO INTERVENTION

standard Esophagogastroduodenoscopy

cap assisted Esophagogastroduodenoscopy

EXPERIMENTAL

cap assisted Esophagogastroduodenoscopy

Device: Cap

Interventions

CapDEVICE

cap assisted esophagogastroduodenoscopy

cap assisted Esophagogastroduodenoscopy

Eligibility Criteria

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

You may qualify if:

  • Indication of Esophagogastroduodenoscopy independent from the study
  • Written informed
  • Age ≥ 18 years

You may not qualify if:

  • Absence of written informed consent
  • Contraindication or absence of informed consent regarding sedation with Propofol
  • Postoperativ changes of the upper GI-tract
  • Intention of endoscopic intervention
  • Suspicion of upper GI-bleeding
  • Suspicion of stenosis of the esophagus
  • Stent in the papilla duodeni major
  • ASA (American Society of Anesthesiologists) classification ≥ 3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum rechts der Isar der Technischen Universität München

Munich, Bavaria, 81675, Germany

Location

MeSH Terms

Interventions

Contraceptive Devices, Female

Intervention Hierarchy (Ancestors)

Contraceptive DevicesEquipment and Supplies

Study Officials

  • Stefan von Delius

    Technical University of Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

February 29, 2016

First Posted

August 24, 2016

Study Start

February 1, 2016

Primary Completion

May 1, 2016

Study Completion

August 1, 2016

Last Updated

August 24, 2016

Record last verified: 2016-08

Locations

DE(1)