Use of Peppermint Oil During Screening Colonoscopy to Imp... | NCT03286764

Studies
Use of Peppermint Oil During Screening Colonoscopy to Improve Visibility

NCT03286764

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Apr 3, 2020Actual

Enrollment

48Actual

Phase

Not Applicable

Conditions

Enhancement of the ADR During Colonoscopy

Interventions

Peppermint Oil
Distilled water

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Sep 10, 2019Actual

Completion Date

Sep 10, 2019Actual

First Submitted Date

Sep 15, 2017

First Submission Date that Met QC Criteria

Sep 15, 2017

First Posted Date

Sep 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2020

Last Update Posted Date

Apr 3, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators hypothesize that spraying peppermint oil containing L-menthol onto the colonic mucosa during colonoscopy will relax smooth muscle allowing better colonic visualization.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Distilled water spray as a placebo during Colonoscopy	Other: Distilled water
Peppermint Oil	Experimental	Peppermint Oil spray during Colonoscopy	Other: Peppermint Oil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Peppermint Oil	Other		Peppermint Oil
Distilled water

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determination of Adenoma Detection Rate during Colonoscopy Procedure		2 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Screening colonoscopy
Age 50 years and older
Able to give consent

Exclusion Criteria:

No consent obtained or adult lacking capacity to consent
Do not reach cecum on colonoscopy
Renal impairment (defined as CrCl <30 ml/min)
Allergy to study peppermint oil solution
History of colon resection
Inflammatory bowel disease
Known colorectal neoplasia
Non-correctable coagulopathy
Pregnancy or lactating
Prisoners

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kevin C Ruff	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Arizona		Scottsdale	Arizona	85259	United States

Label	URL
Mayo Clinic Clinical Trials	View source

Intervention Browse Module

MeSH Terms

ID	Term
C015424	peppermint oil

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided