Chronic Rhinosinusitis Trial, Completed NCT01990820 Sponsor: Endeavor Health Condition: Chronic Rhinosinusitis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 25 children in total — 13 in one group and 12 in the other. All 25 completed the study, with no drop-outs reported. The trial was comparing two surgical approaches for children with sinus problems: one group received an adenoidectomy (removal of the adenoids) plus a wash-out of the maxillary sinuses (the sinuses behind the cheeks), while the other group received the same procedure but with the addition of a balloon dilation to widen the sinus opening. The main thing being measured was quality of life, as reported by each child's caregiver using a questionnaire called the SN-5. The reported data shows that caregivers rated their child's sinus-related quality of life using the SN-5 scale, where a score of 1 means the best possible quality of life and 7 means the worst. Before surgery, the group without balloon dilation had an average score of 2.48, and the group with balloon dilation scored 2.50 — very similar starting points. At 12 months after surgery, the scores were 2.25 and 2.40 respectively. Caregivers also gave an overall quality of life rating on a separate 0–10 scale (where 10 is the best). The reported data shows that at 12 months, the without-balloon group averaged 8.27 and the with-balloon group averaged 7.60 on this scale. Earlier post-surgery scores (likely at 6 months) were 8.10 and 8.27 respectively. It is worth noting that this was a small trial with 25 participants, and only the scores themselves were reported in the submitted data — no information about whether any differences between the two groups were considered meaningful was included in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Chronic Rhinosinusitis Trial, Completed

NCT01990820
Completed Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have had sinus symptoms lasting at least 12 weeks, or you get sinus infections more than 3 times a year
  • You have already tried antibiotics for at least 3 weeks, plus nasal steroid sprays or antihistamines for at least 3 months, and saline nasal rinses, but these treatments did not help
  • A CT scan (a detailed type of X-ray) has confirmed that you have sinusitis after completing a course of antibiotics

Who may not be able to join:

  • You have large nasal polyps (growths inside the nose), significant new bone growth in the sinuses, or a tumor in the nose or sinuses
  • You have had a facial injury in the past that changed the shape or structure of your sinuses
  • You have a condition that affects how the tiny hair-like structures in your airways work (confirm with trial site)
  • You are pregnant
  • You have cystic fibrosis, a condition affecting the structure of your face or skull, a metabolic disorder, or a weakened immune system
  • You have had your adenoids removed and may need a type of sinus surgery called functional endoscopic sinus surgery
  • You have had previous sinus surgery, or your CT scan shows significant structural problems that would require sinus surgery or surgery to straighten the wall inside your nose

Please note: Children who are having another surgery at the same time are not automatically excluded from this trial.


Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

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Trial details

Status
Completed
Phase
Not Applicable
Sponsor
Endeavor Health
Registry
ClinicalTrials.gov
Start date
1 March 2009
Est. completion
29 September 2016

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Quality of Life (QoL) Outcomes Between Adenoidectomy + Maxillary Sinus Irrigation With or Without the Use of Balloon Dilation or Maxillary Sinus Ostia.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov