Balloon Sinusotomy for Sinusitis

Overseen By Dennis M Tang, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Previous sinus surgery, Nasal polyps, Cystic fibrosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the research is to examine the effectiveness of navigation in maxillary sinus balloon dilation for the treatment of chronic maxillary rhinosinusitis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the treatment Maxillary Balloon Sinusotomy for sinusitis?

Research shows that balloon sinuplasty, a similar treatment, can reduce nasal airway resistance and improve symptoms in patients with chronic sinusitis. Additionally, studies indicate that balloon dilation is a feasible and effective option for treating maxillary sinus issues, with patients reporting symptom improvement and no complications. ^{1 2 3 4 5}

Is balloon sinusotomy generally safe for humans?

Balloon sinusotomy is generally considered safe, with studies showing it has a good safety record. However, like any procedure, there can be risks, including minor complications and, in rare cases, more serious issues like bleeding or injury to nearby areas. ^{6 7 8 9 10}

How is the treatment Maxillary Balloon Sinusotomy different from other treatments for sinusitis?

Maxillary Balloon Sinusotomy is a minimally invasive treatment that uses a small balloon to gently open blocked sinus pathways, similar to angioplasty used in heart procedures. This approach is less invasive than traditional sinus surgery, potentially offering quicker recovery and fewer complications. ^{3 4 11 12 13}

Eligibility Criteria

This trial is for adults over 18 who have chronic sinusitis in the maxillary sinuses and haven't improved with medication. They should be candidates for their first sinus surgery but can't have nasal polyps.

Inclusion Criteria

My condition did not improve with medication.

I am a candidate for sinus surgery due to chronic sinusitis without nasal polyps.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo maxillary balloon sinusotomy with or without navigation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

1-2 visits (in-person)

Long-term follow-up

Participants are monitored for long-term outcomes and success rate

12 months

Treatment Details

Interventions

• Maxillary Balloon Sinusotomy

Trial Overview The study is testing how well a navigation system helps doctors when they use a balloon to open up the sinuses in patients with chronic maxillary sinusitis.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Findings from Research

Both balloon sinuplasty and uncinectomy significantly improved symptoms of chronic rhinosinusitis, as measured by the Sinonasal Outcome Test-22, with no significant difference in effectiveness between the two procedures.

Balloon sinuplasty had a lower risk of postoperative complications, specifically synechia, making it a safer option despite its higher material costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decrease of nasal airway resistance and alleviations of symptoms after balloon sinuplasty in patients with isolated chronic rhinosinusitis: a prospective, randomised clinical study. Bizaki, AJ., Numminen, J., Taulu, R., et al.[2017]

In a study of 65 patients followed for two years after balloon catheter sinusotomy, significant improvements in sinus symptoms were observed, with 85% of patients reporting symptom relief and stable outcomes over time.

Radiographic assessments showed significant and sustained improvements in CT scores, confirming the effectiveness of the procedure in resolving sinus disease, with a low revision rate of only 3.6%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcome analysis of balloon catheter sinusotomy: two-year follow-up. Weiss, RL., Church, CA., Kuhn, FA., et al.[2012]

Balloon dilation of the maxillary os was successfully performed on 5 sinuses in a case series of 4 patients, with no complications reported, suggesting it is a safe treatment option for chronic maxillary atelectasis.

All patients experienced subjective improvement in symptoms, and follow-up confirmed successful aeration of the sinuses without restenosis, indicating the efficacy of this method; however, further studies with larger samples are needed to fully validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of chronic maxillary atelectasis using balloon dilation. Sun, DQ., Dubin, MG.[2016]

Balloon sinuplasty is a minimally invasive endoscopic technique designed to open blocked sinus pathways, similar to how angioplasty works for blood vessels.

The article reviews both the procedural methods and existing literature, along with the author's personal experiences, emphasizing the effectiveness and safety of this technique in treating sinus obstructions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balloon sinuplasty. Ahmad, Z.[2021]

In a study of 159 patients with chronic rhinosinusitis, balloon sinuplasty was associated with a higher risk of needing revision surgery compared to traditional endoscopic sinus surgery (ESS), with 17 balloon patients requiring revision versus 6 ESS patients.

Despite the higher revision rates, patient satisfaction was similar, with 82% of ESS patients and 75% of balloon patients reporting they were very satisfied with their surgery, indicating that both procedures can effectively improve symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Follow-Up After Maxillary Sinus Balloon Sinuplasty and ESS. Koskinen, A., Lundberg, M., Lilja, M., et al.[2023]

A retrospective analysis of adverse events related to balloon dilation of paranasal sinus ostia identified 114 incidents, with the most common being patient injuries (72 cases), particularly orbital complications and skull base injuries.

While adverse events are relatively uncommon given the number of procedures performed, some can be severe, highlighting the importance for surgeons to be aware of specific complications associated with different sinus surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Analysis of Adverse Event Reporting in Balloon Sinus Procedures. Prince, A., Bhattacharyya, N.[2016]

A retrospective analysis of the FDA's MAUDE database from 2008 to 2018 identified 211 adverse events related to balloon sinuplasty, with the most common complications being device malfunctions and patient-related issues like cerebrospinal fluid leaks and eye swelling.

The study highlighted that balloon and guide catheter malfunctions were the leading device-related complications, while significant eye swelling occurred frequently during procedures involving the maxillary sinus, emphasizing the need for healthcare providers to inform patients about these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Associated with Balloon Sinuplasty: A MAUDE Database Analysis. Hur, K., Ge, M., Kim, J., et al.[2020]

In a study involving 1,036 patients across 27 US otolaryngology practices, balloon catheters used in sinus surgery demonstrated a high safety profile with no major adverse events and a low revision rate of only 1.3% after an average follow-up of 40.2 weeks.

The use of balloon catheters significantly improved sinus symptoms in 95.2% of patients, and postoperative sinus infections were less frequent and less severe, indicating that this technique enhances patient quality of life effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter registry of balloon catheter sinusotomy outcomes for 1,036 patients. Levine, HL., Sertich, AP., Hoisington, DR., et al.[2019]

In a study involving 307 sinuses over 24 weeks, balloon catheter devices successfully maintained sinus ostia patency in 80.5% of cases, demonstrating their effectiveness in treating obstructed sinuses.

The procedure showed a low rate of adverse events, with only 0.98% of sinuses requiring revision treatment, and patients reported consistent improvement in symptoms as measured by the Sino-Nasal Outcome Test (SNOT 20).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and outcomes of balloon catheter sinusotomy: a multicenter 24-week analysis in 115 patients. Bolger, WE., Brown, CL., Church, CA., et al.[2012]

Endoscopic sinus surgery has a strong safety record that continues to improve due to advancements in surgical techniques and equipment, making it fundamentally safe for patients.

Despite its safety, there are still risks of serious complications such as blindness, cerebrospinal fluid leaks, and intracranial injuries, which require careful management and avoidance strategies during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of intracranial complications of sinus surgery. Schnipper, D., Spiegel, JH.[2004]

The balloon dilatation technique using a Foley catheter for treating intramaxillary lesions in chronic maxillary sinusitis was found to be minimally invasive and effective, with no significant intraoperative or postoperative complications reported in a study of 34 patients.

Postoperative outcomes, including symptom relief and lesion resolution, were comparable to those achieved with traditional functional endoscopic sinus surgery, suggesting this method is a viable alternative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A balloon dilatation technique for the treatment of intramaxillary lesions using a Foley catheter in chronic maxillary sinusitis. Park, CH., Kim, HS., Lee, JH., et al.[2012]

Functional endoscopic sinus surgery (FESS) has replaced radical sinus surgery as the gold standard for treating maxillary sinus diseases due to its lower morbidity and improved outcomes.

Different types of sinusotomy (I, II, and III) allow for tailored surgical approaches based on the specific anatomy and pathology of the sinus, ensuring effective treatment for various conditions such as chronic sinusitis, nasal polyps, and fungal infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Radicality of maxillary sinus surgery and size of the maxillary sinus ostium]. Sommer, F., Hoffmann, T., Lindemann, J., et al.[2020]

Balloon sinus dilation (BSD) effectively widened the openings of maxillary and frontal sinuses in 9 patients with chronic rhinosinusitis, although there were some unsuccessful attempts.

The procedure resulted in a shorter recovery time and quicker return to work due to its minimally invasive nature, with significant improvements in patient-reported outcomes measured by the SNOT-22 survey one day and one month post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balloon sinuplasty in one-day surgery. Fijałkowska-Ratajczak, T., Kopeć, J., Leszczyńska, M., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Decrease of nasal airway resistance and alleviations of symptoms after balloon sinuplasty in patients with isolated chronic rhinosinusitis: a prospective, randomised clinical study. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Long-term outcome analysis of balloon catheter sinusotomy: two-year follow-up. [2012]

3. England pubmed.ncbi.nlm.nih.gov

Treatment of chronic maxillary atelectasis using balloon dilation. [2016]

4. India pubmed.ncbi.nlm.nih.gov

Balloon sinuplasty. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Long-Term Follow-Up After Maxillary Sinus Balloon Sinuplasty and ESS. [2023]

6. England pubmed.ncbi.nlm.nih.gov

An Analysis of Adverse Event Reporting in Balloon Sinus Procedures. [2016]

7. England pubmed.ncbi.nlm.nih.gov

Adverse Events Associated with Balloon Sinuplasty: A MAUDE Database Analysis. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Multicenter registry of balloon catheter sinusotomy outcomes for 1,036 patients. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Safety and outcomes of balloon catheter sinusotomy: a multicenter 24-week analysis in 115 patients. [2012]

10. United States pubmed.ncbi.nlm.nih.gov

Management of intracranial complications of sinus surgery. [2004]

11. United States pubmed.ncbi.nlm.nih.gov

A balloon dilatation technique for the treatment of intramaxillary lesions using a Foley catheter in chronic maxillary sinusitis. [2012]

12. Germany pubmed.ncbi.nlm.nih.gov

[Radicality of maxillary sinus surgery and size of the maxillary sinus ostium]. [2020]

13. Poland pubmed.ncbi.nlm.nih.gov

Balloon sinuplasty in one-day surgery. [2022]