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Rates of Middle Meatus Synechiae Formation Post Endoscopic Sinus Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02627794
Recruitment Status : Terminated (Due to financial issues of Restora spacer company.)
First Posted : December 11, 2015
Results First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Martin L. Hopp, MD, Cedars-Sinai Medical Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Sinusitis
Interventions Device: Restora™ Steroid eluting spacer
Device: Silastic Silicone Spacer
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Restora™ Steroid Eluting & Silastic Silicone Spacers
Hide Arm/Group Description

This study arm receives both the experimental treatment, a Restora™ Steroid eluting spacer and Silastic Silicone spacer.

Both spacers 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.

Period Title: Overall Study
Number of participants Number of units (nasal)
Started 3 6
Completed 3 6
Not Completed 0 0
Arm/Group Title Restora™ Steroid Eluting & Silastic Silicone Spacer
Hide Arm/Group Description

This arm receives both Restora™ Steroid eluting & Silastic Silicone spacers.

The Restora™ Steroid eluting and Silastic Silicone Spacers 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.

Overall Number of Baseline Participants 3
Overall Number of Units Analyzed
Type of Units Analyzed: Nose
6
Hide Baseline Analysis Population Description
Each participant received a Restora Spacer on one nostril and a silicone spacer on the other nostril. We had 3 participants in total, but each received two spacers.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
2
  66.7%
Male
1
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Incidence of Middle Meatal Synechiae After Endoscopic Sinus Surgery in Silastic and Restora Steroid Eluting Spacer.
Hide Description 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.
Time Frame Participants will be followed for the duration of post op standard of care, an expected average of 90 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Silastic Silicone Spacer Restora™ Steroid Eluting Spacer
Hide Arm/Group Description:

Silastic Silicone spacers are actively being used as the standard of care.

Silastic Silicone Spacer: 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.

This study arm receives the experimental treatment, a Restora™ Steroid eluting spacer.

Restora™ Steroid eluting spacer: 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.

Overall Number of Participants Analyzed 3 3
Measure Type: Count of Participants
Unit of Measure: Participants
3
 100.0%
3
 100.0%
2.Secondary Outcome
Title 90-day Sinonasal Mucosal Inflammation Assessment
Hide Description 90-day sinonasal mucosal inflammation assessed by rigid endoscopy and graded on Lund-Kennedy sinus mucosal endoscopic staging system
Time Frame Participants will be followed for the duration of post op standard of care, an expected average of 90 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.
Arm/Group Title Restora™ Steroid Eluting & Silastic Silicone Spacer
Hide Arm/Group Description:

This arm receives both Restora™ Steroid eluting & Silastic Silicone spacers.

The Restora™ Steroid eluting and Silastic Silicone Spacers 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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title 35 and 90-day Intraocular Pressure (IOP) Assessment
Hide Description 35 and 90-day intraocular pressure (IOP) assessed using applanation tonometry and compared to baseline IOP obtained preoperatively
Time Frame Participants will be followed for the duration of post op standard of care, an expected average of 90 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.
Arm/Group Title Restora™ Steroid Eluting & Silastic Silicone Spacer
Hide Arm/Group Description:

This arm receives both Restora™ Steroid eluting & Silastic Silicone spacers.

The Restora™ Steroid eluting and Silastic Silicone Spacers 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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title 35 and 90-day Post ESS Incidence of Middle Meatal Synechiae
Hide Description 35 and 90-day post ESS incidence of middle meatal synechiae
Time Frame Participants will be followed for the duration of post op standard of care, an expected average of 90 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.
Arm/Group Title Restora™ Steroid Eluting & Silastic Silicone Spacer
Hide Arm/Group Description:

This arm receives both Restora™ Steroid eluting & Silastic Silicone spacers.

The Restora™ Steroid eluting and Silastic Silicone Spacers 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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title 90-day Sinonasal Outcomes Test-22 (SNOT- 22) Scores
Hide Description 90-day Sinonasal Outcomes Test-22 (SNOT- 22) scores
Time Frame Participants will be followed for the duration of post op standard of care, an expected average of 90 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.
Arm/Group Title Restora™ Steroid Eluting & Silastic Silicone Spacer
Hide Arm/Group Description:

This arm receives both Restora™ Steroid eluting & Silastic Silicone spacers.

The Restora™ Steroid eluting and Silastic Silicone Spacers 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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title 35-day Frequency of Postoperative Interventions
Hide Description 35-day frequency of postoperative interventions, including lyses of adhesions and debridement.
Time Frame Participants will be followed for the duration of post op standard of care, an expected average of 90 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.
Arm/Group Title Restora™ Steroid Eluting & Silastic Silicone Spacer
Hide Arm/Group Description:

This arm receives both Restora™ Steroid eluting & Silastic Silicone spacers.

The Restora™ Steroid eluting and Silastic Silicone Spacers 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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title 35-day Frequency of Oral Steroid Rescue
Hide Description 35-day frequency of oral steroid rescue
Time Frame Participants will be followed for the duration of post op standard of care, an expected average of 90 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.
Arm/Group Title Restora™ Steroid Eluting & Silastic Silicone Spacer
Hide Arm/Group Description:

This arm receives both Restora™ Steroid eluting & Silastic Silicone spacers.

The Restora™ Steroid eluting and Silastic Silicone Spacers 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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title 35 Days Middle Turbinate Position
Hide Description 35 days middle turbinate position
Time Frame Participants will be followed for the duration of post op standard of care, an expected average of 90 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.
Arm/Group Title Restora™ Steroid Eluting & Silastic Silicone Spacer
Hide Arm/Group Description:

This arm receives both Restora™ Steroid eluting & Silastic Silicone spacers.

The Restora™ Steroid eluting and Silastic Silicone Spacers 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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Silastic Silicone Spacer Restora™ Steroid Eluting Spacer
Hide Arm/Group Description

Silastic Silicone spacers are actively being used as the standard of care.

Silastic Silicone Spacer: 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.

This study arm receives the experimental treatment, a Restora™ Steroid eluting spacer.

Restora™ Steroid eluting spacer: 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.

All-Cause Mortality
Silastic Silicone Spacer Restora™ Steroid Eluting Spacer
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%) 
Hide Serious Adverse Events
Silastic Silicone Spacer Restora™ Steroid Eluting Spacer
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Silastic Silicone Spacer Restora™ Steroid Eluting Spacer
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Martin L. Hopp
Organization: Cedars-Sinai Medical Center
Phone: 310-657-7704
EMail: marty@towerent.com
Layout table for additonal information
Responsible Party: Martin L. Hopp, MD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02627794    
Other Study ID Numbers: Pro00039737
First Submitted: December 7, 2015
First Posted: December 11, 2015
Results First Submitted: April 10, 2017
Results First Posted: November 17, 2017
Last Update Posted: November 17, 2017