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Nasal Saline Irrigation for Pituitary Disease (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
Must not have
Concurrent antibiotics for another indication (i.e., urinary tract infection)
Active sinus infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking antibiotics for a condition other than cancer.
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I currently have a sinus infection.
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I have a long-term history of sinus infections.
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I have a weakened immune system.
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I have had surgery on my sinuses before.
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I have nasal polyps.
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I have been diagnosed with Cushing's disease.
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I have had radiation treatment to the base of my skull.
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I currently have sinusitis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Difference in mean sinonasal quality of life
Secondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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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