NCT02958722

Brief Summary

The investigators aim to enroll 2000 patients to undergo diagnostic hysteroscopy for suspected uterine pathologies. Women will be randomized into two groups on the basis of distension medium : group A CO2; group B physiological solution. Pain discomfort will be evaluated after the examination.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

October 21, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

October 6, 2017

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

October 21, 2016

Last Update Submit

October 5, 2017

Conditions

Hysteroscopy, Distension Medium, Pain

Outcome Measures

Primary Outcomes (1)

  • pain discomfort during the procedure assessed through visual analogue scale (VAS)

    up to six months

Study Arms (2)

carbon dioxide

ACTIVE COMPARATOR

Diagnostic hysteroscopy performed with the carbon dioxide (gas)

Procedure: diagnostic hysteroscopyDrug: carbon dioxide

physiological solution

ACTIVE COMPARATOR

Diagnostic hysteroscopy performed with liquid solution (physiologic solution)

Procedure: diagnostic hysteroscopyDrug: physiological solution

Interventions

diagnostic hysteroscopyPROCEDURE

Endoscopic procedure to visualize uterine cavity

carbon dioxidephysiological solution
physiological solutionDRUG
physiological solution
carbon dioxideDRUG
carbon dioxide

Eligibility Criteria

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

You may qualify if:

  • suspected uterine pathologies
  • infertility

You may not qualify if:

  • pregnancy
  • severe hypertension, cardiovascular disease or respiratory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Interventions

HysteroscopyCarbon Dioxide

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and GynecologicalDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeObstetric Surgical ProceduresGynecologic Surgical ProceduresUrogenital Surgical ProceduresCarbon Compounds, InorganicInorganic ChemicalsGasesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2016

First Posted

November 8, 2016

Study Start

November 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

October 6, 2017

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share