NCT03663491

Brief Summary

Evaluation of patients safety and comfort in nasal endoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
283

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 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

September 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
Last Updated

May 22, 2019

Status Verified

May 1, 2018

Enrollment Period

7 months

First QC Date

June 21, 2018

Last Update Submit

May 20, 2019

Conditions

Patient Safety

Keywords

GastroscopyTransnasal EndoscopySedation

Outcome Measures

Primary Outcomes (1)

  • Patients satisfaction (pain, discomfort, experience)

    Satisfaction with the procedure: * not at all * hardly * moderately * quite * extraordinarily (extraordinarily = the best possible outcome, not at all = the worst possible outcome)

    During Endoscopy procedure

Secondary Outcomes (2)

  • Pain during the procedure

    During Endoscopy procedure

  • Previous experience with endoscopy

    Before Endoscopy procedure

Study Arms (3)

Unsedated Nasal Gastroscopy

EXPERIMENTAL

Transnasal Endoscopy. No sedation used. Use of local anesthesia.

Procedure: Nasal GastroscopyProcedure: Oral Gastroscopy with transnasal endoscope, sedated

Oral Gastroscopy, unsedated

ACTIVE COMPARATOR

Transoral Endoscopy. No sedation used. Use of local anesthesia.

Procedure: Oral Gastroscopy, unsedated

Oral Gastroscopy, sedated

ACTIVE COMPARATOR

Transoral Endoscopy. Intravenous sedation used.

Procedure: Oral Gastroscopy, sedated

Interventions

Nasal GastroscopyPROCEDURE

Use of transnasal endoscopes for routine gastroscopy in adults.

Unsedated Nasal Gastroscopy
Oral Gastroscopy, unsedatedPROCEDURE

Use of transoral endoscopes for routine gastroscopy in adults. Use of local anesthesia.

Oral Gastroscopy, unsedated
Oral Gastroscopy, sedatedPROCEDURE

Use of transoral endoscopes for routine gastroscopy in adults. Use of intravenous sedation.

Oral Gastroscopy, sedated
Oral Gastroscopy with transnasal endoscope, sedatedPROCEDURE

Use of transnasal endoscopes for routine gastroscopy in adults, following a failed attempt to perform transnasal gastroscopy

Unsedated Nasal Gastroscopy

Eligibility Criteria

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

You may qualify if:

  • Informed consent
  • Adequate knowledge of oral and written german

You may not qualify if:

  • Inpatient Treatment
  • For medical reasons (narrow nasal cavity, band ligation of esophageal varices, Placement of a percutaneous endoscopic gastrostomy, planned colonoscopy under sedation the same day, abnormal coagulation, emergency procedures)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leipzig

Leipzig, 04103, Germany

Location

Related Publications (1)

  • Schuldt AL, Kirsten H, Tuennemann J, Heindl M, van Bommel F, Feisthammel J, Hollenbach M, Hoffmeister A. Necessity of transnasal gastroscopy in routine diagnostics: a patient-centred requirement analysis. BMJ Open Gastroenterol. 2019 Apr 14;6(1):e000264. doi: 10.1136/bmjgast-2018-000264. eCollection 2019.

    PMID: 31139423DERIVED

MeSH Terms

Interventions

Gastroscopy

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Albrecht Hoffmeister, Prof Dr

    University of Leipzig

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2018

First Posted

September 10, 2018

Study Start

September 1, 2016

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

May 22, 2019

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share

All data will be available to other researchers on request. (Mail to juergen.feisthammel@medizin.uni-leipzig.de)

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
All data will be available to other researchers on request. (Mail to juergen.feisthammel@medizin.uni-leipzig.de)
Access Criteria
All data will be available to other researchers on request. (Mail to juergen.feisthammel@medizin.uni-leipzig.de)

Locations

DE(1)