Rates of Middle Meatus Synechiae Formation Post Endoscopic Sinus Surgery

NCT02627794 | Terminated Phase 3 Results

• 1 other identifier: Pro00039737
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic sinus surgery (ESS) is the gold standard surgical intervention for chronic rhinosinusitis that is not adequately controlled with maximal medical therapy. In some patients, underlying inflammation (discharge, edema and polyposis), compounded by inflammation caused by surgical trauma may lead to an uncontrolled healing response, which results in the synechiae formation in the middle meatus (MM). Incidence of synechiae formation varies in literature and ranges between 4-35%. Presence of middle meatal synechiae can impair sinus drainage, promote sinusitis, and limit endoscopic visualization of the sinus cavities postoperatively. This may result in difficulty in performing postoperative routine endoscopic debridement and examination, which is paramount to a successful outcome from ESS. Spacers are often inserted during surgery between nasal mucosal surfaces to prevent synechiae. The aim of this study is to see if a steroid-impregnated spacer is more effective at reducing inflammation after sinus surgery than a Silastic spacer.

Conditions

Sinusitis

Keywords

Middle Meatus; Synechiae; Endoscopic Sinus Surgery; Silastic spacer; Restora™ steroid eluting MM spacer

Outcome Measures

Primary Outcomes (1)

• Incidence of Middle Meatal Synechiae After Endoscopic Sinus Surgery in Silastic and Restora Steroid Eluting Spacer.

  The main objective of the trial is to evaluate basic device usability and confirm safety and effectiveness of Restora™ Mometasone Furoate eluting spacer as compared to a Silastic spacer. 35-day sinonasal mucosal inflammation will be assessed by rigid endoscopy and graded on Lund-Kennedy sinus mucosal endoscopic staging system.

  Participants will be followed for the duration of post op standard of care, an expected average of 90 days.

Secondary Outcomes (7)

• 90-day Sinonasal Mucosal Inflammation Assessment

  Participants will be followed for the duration of post op standard of care, an expected average of 90 days.

• 35 and 90-day Intraocular Pressure (IOP) Assessment

  Participants will be followed for the duration of post op standard of care, an expected average of 90 days.

• 35 and 90-day Post ESS Incidence of Middle Meatal Synechiae

  Participants will be followed for the duration of post op standard of care, an expected average of 90 days.

• 90-day Sinonasal Outcomes Test-22 (SNOT- 22) Scores

  Participants will be followed for the duration of post op standard of care, an expected average of 90 days.

• 35-day Frequency of Postoperative Interventions

  Participants will be followed for the duration of post op standard of care, an expected average of 90 days.

Study Arms (1)

Silastic Silicone & Restora™ Steroid eluting spacer

EXPERIMENTAL

Silastic Silicone spacers are actively being used as the standard of care. Restora™ Steroid eluting spacer (experimental). Each nostril will receive one each of above spacers.

Device: Restora™ Steroid eluting spacer; Device: Silastic Silicone Spacer

Interventions

Restora™ Steroid eluting spacer DEVICE

The Restora™ Steroid eluting spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery.

Also known as: Experimental arm

Silastic Silicone & Restora™ Steroid eluting spacer

Silastic Silicone Spacer DEVICE

The Silastic Silicone Spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery.

Also known as: Control Arm

Silastic Silicone & Restora™ Steroid eluting spacer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years
• Diagnosis of chronic rhinosinusitis (CRS), per current guidelines
• Patients who need to undergo primary bilateral complete endoscopic sinus surgery
• Subject has the ability to follow the study instructions, is willing to be available on the specific required study visit days, and is willing to complete all study visit procedures and assessments
• Subject must understand the research nature of this study and sign an informed consent prior to the performance of any study-specific procedure or assessment

You may not qualify if:

• Subject is pregnant or breast feeding
• Patients with sino-nasal tumors
• Patients solely undergoing nasal septal reconstruction
• Patients with previous history of endoscopic sinus surgery
• Cystic fibrosis or syndromic patients
• Patients with autoimmune diseases
• Patients who have taken oral steroids less than 30 days prior to surgery
• Patients with a history or diagnosis of glaucoma or ocular hypertension
• Any other circumstance or condition that in the Investigator's opinion causes the subject to be an inappropriate candidate for participating in this study

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Dr. Martin L. Hopp
• Organization: Cedars-Sinai Medical Center

marty@towerent.com

310-657-7704

Study Officials

• Martin L Hopp, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: December 11, 2015
• Study Start: December 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: November 17, 2017
• Results First Posted: November 17, 2017

Record last verified: 2017-10

Locations

US (1)