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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a procedure called maxillary balloon sinusotomy for individuals with chronic maxillary rhinosinusitis, a condition causing persistent sinus problems. The procedure uses navigation tools, making it less invasive than traditional surgery. Suitable candidates have ongoing sinus issues that have not improved with other treatments and are considering sinus surgery for the first time. As a Phase 2, Phase 3 trial, this research assesses the procedure's effectiveness in a smaller group and represents the final step before FDA approval, offering participants an opportunity to contribute to the development of an innovative treatment.

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 prior data suggests that maxillary balloon sinusotomy is safe for treating chronic maxillary rhinosinusitis?

Research has shown that using a balloon to open the sinuses is generally safe for treating long-term sinus problems. In a study with 115 patients, the procedure proved safe over a 24-week period. Another study found that using a sinus balloon can help reduce complications in people with chronic sinus issues. Additionally, long-term results suggest that this treatment is both safe and effective.

Overall, these studies indicate that the procedure is well-tolerated, with few serious side effects reported. Most people who undergo the procedure do not experience major problems. For those considering joining a trial for this treatment, existing research offers reassurance about its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Balloon Sinusotomy for sinusitis is unique because it offers a minimally invasive alternative to traditional sinus surgery. Unlike conventional treatments that may involve cutting tissue to clear sinus blockages, this technique uses a small balloon to gently dilate the sinus passages, which can reduce pain and recovery time. Researchers are excited about this method because it has the potential to be safer and more comfortable for patients, with quicker recovery and fewer complications compared to the standard endoscopic sinus surgery.

What evidence suggests that maxillary balloon sinusotomy is effective for chronic maxillary rhinosinusitis?

Studies have shown that maxillary balloon sinusotomy, a type of balloon sinuplasty, effectively treats long-term sinus infections in the cheek area. Research indicates that this procedure is safe and can provide lasting relief for patients. Some studies found that only a small number of patients required additional sinus surgery afterward, suggesting successful initial results. Overall, the procedure reduces complications and offers a promising solution for those with chronic sinus problems. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

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 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3738804/

Efficacy & Outcomes of Balloon Sinuplasty in Chronic ... The average surgery time was 73 min. Of the 1,036 patients treated, 25 patients (2.4%) required revision of sinuses [11]. In our study the mean average ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0196070920305196

Long term outcomes of balloon sinuplasty for the treatment ... Conclusion. Balloon sinuplasty appears to be safe and effective for the treatment of CRS with great long-term outcomes.

3. journals.lww.com journals.lww.com/md-journal/fulltext/2025/06130/efficacy_and_safety_of_sinus_balloon_catheter.8.aspx

Efficacy and safety of sinus balloon catheter dilation versus ... The results indicated that SBCD was an effective intervention for CRS, capable of substantially decreasing the occurrence of complications.

4. journals.sagepub.com journals.sagepub.com/doi/10.1177/0145561320986030

Long-Term Follow-Up After Maxillary Sinus Balloon ... In this study, the revision numbers of specific sinuses were reported and the revision rate after maxillary sinus operation was 4.3%. Our ESS ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12173261/

Efficacy and safety of sinus balloon catheter dilation versus ... The results indicated that SBCD was an effective intervention for CRS, capable of substantially decreasing the occurrence of complications.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10909022/

Balloon Sinuplasty: Our Experience - PMC Balloon sinuplasty is an excellent procedure which is safe and highly effective for medically nonresponsive CRS without polyposis. The success ...

7. anthem.com anthem.com/medpolicies/abc/active/gl_pw_d080140.html

CG-SURG-73 Balloon Sinus Ostial Dilation The main outcome measured was resolution of frontal sinus disease as shown by CT scan at 12 months. The authors reported that 80.76% of the operative balloon ...