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Nasal saline irrigation for Pituitary Tumors (NOSE Trial)

N/A

Recruiting

Research Sponsored by Lori Wood

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults aged over 18 and under 85 years

Diagnosed with nonfunctioning adenoma, acromegaly, prolactinoma, or Rathke's cleft cyst

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

NOSE Trial Summary

This trial aims to study the benefits of using nasal irrigations after pituitary surgery. The study will be conducted at multiple centers and will provide important data to help create new guidelines for postoperative care

Who is the study for?

This trial is for adults aged 18-85 who are undergoing endoscopic surgery to remove pituitary tumors. Participants must speak English and be able to understand specific nasal condition questionnaires. They should not have any conditions that make joining the study risky, as judged by the investigator.Check my eligibility

What is being tested?

The study is testing if nasal saline irrigation helps patients recover after endonasal pituitary surgery. It's a forward-looking, single-blinded test across multiple centers aiming to set new guidelines based on how these irrigations affect post-surgery recovery.See study design

What are the potential side effects?

While not explicitly listed in the provided information, typical side effects of nasal saline irrigation may include discomfort or irritation in the nose, sneezing, and rarely nosebleeds or infections.

NOSE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 85 years old.

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I have been diagnosed with a specific type of pituitary tumor or cyst.

NOSE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Difference in mean sinonasal quality of life

Secondary outcome measures

Endoscopy findings

Sinonasal quality of life as determined by SNOT-22 rhinological subscale scores

Sinonasal quality of life as determined by Sinonasal Outcomes Test 22 (SNOT-22)

+2 more

NOSE Trial Design

2Treatment groups

Active Control

Group I: Nasal saline irrigationActive Control1 Intervention

Patients randomized to standard postoperative nasal care with twice a day saline sinonasal irrigations

Group II: No InterventionActive Control1 Intervention

Patients randomized to not performing saline sinonasal irrigations.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lori WoodLead Sponsor

Nicole HillLead Sponsor

1 Previous Clinical Trials

30 Total Patients Enrolled

Barrow Brain and SpineUNKNOWN

1 Previous Clinical Trials

30 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial include individuals aged 35 and above?

"According to the enrolment criteria, participants must be between 19 and 85 years of age. Separate research designs exist for those under 18 or over 65."

Answered by AI

Is recruitment for this experiment open at the present time?

"According to the clinicaltrials.gov website, this scientific experiment is actively recruiting patients; its inception was on December 18th 2020 and there has been recent activity as of December 19th 2022."

Answered by AI

What is the current enrollment capacity of this trial?

"Affirmative. The information found on clinicaltrials.gov confirms that, as of the most recent update from December 19th 2022, this medical study is actively searching for participants across two sites with a total goal of 140 patients recruited."

Answered by AI

Are there specific demographics that are particularly suited for this research endeavor?

"This clinical trial needs 140 participants between the ages of 19 and 85 that are afflicted with pituitary adenoma. In order to meet all criteria for enrollment, potential patients must be adults above 18 years old, able to comprehend English and take two scales (ASK Nasal-12 & SNOT-22), free from any physical or mental health issues deemed a detriment by investigators, opt for binostril surgical approach with/without septal flap reconstruction."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery

Lori Wood 2020. "Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05659524.

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