NCT05214079

Brief Summary

Determine the force required to occlude the esophagus with a left paratracheal pressure

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

January 14, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

January 28, 2022

Status Verified

January 1, 2022

Enrollment Period

5 months

First QC Date

January 14, 2022

Last Update Submit

January 27, 2022

Conditions

Oesophageal Reflux

Outcome Measures

Primary Outcomes (1)

  • Necessary force of Left paratracheal pressure to occlude the esophagus in female versus male . an up and down method will define the CP 50 in each gender. A comparison between CP50 in both sex will define exactly our outcome

    24 hours

Study Arms (2)

1 , Left paratracheal pressure

ACTIVE COMPARATOR

50 male

Device: Left paratracheal pressure

2, Left paratracheal pressure

ACTIVE COMPARATOR

50 female

Device: Left paratracheal pressure

Interventions

Left paratracheal pressureDEVICE

Applying Left Paratracheal pressure and testing its effectiveness using gastric tube . in addition , by using the dynamometer , the CP 50 is defined.

1 , Left paratracheal pressure2, Left paratracheal pressure

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physical status score 1 or 2
  • No contre indication to Left Paratracheal pressure

You may not qualify if:

  • Obese patients
  • Physical status score 3, 4 or 5
  • Contre indication to Left Paratracheal pressure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Benjamin Javillier, MD

CONTACT

43667180javillier.benjamin@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 14, 2022

First Posted

January 28, 2022

Study Start

March 1, 2022

Primary Completion

July 30, 2022

Study Completion

September 1, 2022

Last Updated

January 28, 2022

Record last verified: 2022-01