Latera RCT - Latera vs. Sham Control for Lateral Nasal Valve Collapse

NCT03400787 | Completed Results DMC FDA Device

• 1 other identifier: CP 04
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 11

Brief Summary

The primary objective of the LATERA RCT is to demonstrate the superiority of the Latera Implant to improve nasal breathing, compared with a Sham Control procedure.

Conditions

Nasal Valve Collapse; Nasal Breathing

Keywords

nasal airway obstruction; sham-control; Polylactide absorbable implant

Outcome Measures

Primary Outcomes (1)

• NOSE Responder Rate

  The primary endpoint of the study is the NOSE Responder Rate, assessed 3 months post-procedure in the per-protocol population of the Latera and Sham arms. The Nasal Obstruction Symptom Evaluation (NOSE) is a validated patient-reported outcome assessment of 5 questions relating to nasal obstruction (congestion, obstruction, trouble breathing through the nose, trouble sleeping, unable to breath through the nose during exercise/exertion. Each question is rated on a Likert scale of 0 (no problem) to 4 (severe problem). The sum of the scores is multiplied by 5 to result in a total score that ranges from 0 to 100. NOSE scores can also be categorized as mild (5-25), moderate (30-50), severe (55-75), and extreme (80-100). A NOSE responder is defined as a participant with at least 1 NOSE class improvement or at least 20% total NOSE score reduction.

  3 months postprocedure.

Secondary Outcomes (1)

• Responder Rate

  7 days, 30 days, and 6, 12, 18 and 24 months.

Study Arms (2)

Sham Control Arm

SHAM COMPARATOR

Subjects in the Sham Control arm will undergo the same preoperative assessments as those in the Latera Treatment arm up to and including anesthesia for the implant, however, no implant will be placed. Crossover - Subjects will be unblinded after the 3-month assessment is complete. Eligible subjects in the Sham Control arm will be treated with the Latera Implant if they still meet all eligibility criteria. Follow up will continue to 24 months post-implant. Subjects who no longer meet the eligibility criteria will exit the study.

Device: Latera Implant

Latera Treatment Arm

EXPERIMENTAL

Subjects in the active treatment arm will receive the Latera Implant using standard techniques. Follow up continues for 24 months post-implant.

Device: Sham Procedure

Interventions

Latera Implant DEVICE

Treatment with implant

Sham Control Arm

Sham Procedure DEVICE

Sham procedure where the Latera delivery device is inserted but no implant delivered.

Latera Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Subjects must meet the following criteria to be included in the study: 1. Adults aged 18 and above; 2. Understands and provides written informed consent; 3. Stated willingness to comply with all study procedures, post-treatment care and availability for the duration of the study follow up of 2 years; 4. In good general health as evidenced by medical history; 5. NOSE score ≥55; 6. Dynamic bi-lateral nasal wall insufficiency as confirmed by Positive Modified Cottle Maneuver; 7. Nasal and facial anatomy appropriate to receive the Latera Implant; 8. Documented failure of benefit after at least 4 weeks of conservative medical management, including, for example, antihistamines or nasal steroids, evidenced by lack of efficacy or tolerability. Subjects meeting any one of the following criteria will be excluded for the study: 1. Unable to tolerate or not a candidate for procedures performed under local anesthesia; 2. Pathology other than lateral wall insufficiency (e.g. septal deviation, turbinate or adenoid hypertrophy, polyps, sinusitis, rhinitis) is the primary contributor to airway obstruction; 3. Requires or is anticipated to require any other concurrent nasal procedures (e.g. Functional Endoscopic Sinus Surgery (FESS), rhinoplasty, sinuplasty, septoplasty, or turbinate reduction) outside of the index procedure within 12 months after the index procedure; 4. FESS, sinuplasty, septoplasty, inferior turbinate reduction, or rhinoplasty within the past 6 months; 5. Any other rhinoplasty procedures are planned or planned usage of external dilators within 24 months after the index procedure; 6. Permanent nasal implant of any type (e.g. autologous, homologous, or synthetic graft) or dilator; 7. Presence of concomitant inflammatory or infectious conditions or unhealed wounds in the treatment area (e.g., vestibulitis, vasculitis, active acne), 8. Currently using chronic systemic steroids or recreational intra-nasal drugs; 9. Currently has cancerous or pre-cancerous nasal lesions, has had radiation in the treatment area, or is currently receiving chemotherapy; 10. History of a significant healing disorders including hypertrophic scarring, or keloid formation; 11. Poorly controlled diabetes mellitus; 12. Known or suspected allergy to PLA or other absorbable implant materials in the Latera Implant; 13. Severe obstructive sleep apnea (OSA) and cannot or is unwilling to refrain from continuous positive airway pressure (CPAP) for up to 2 weeks post-procedure based on expected healing needs and mask types, in agreement with the treating physician; 14. Female subjects, of child bearing potential, known or suspected to be pregnant or are lactating; 15. Any other presenting condition that, in the medical opinion of the investigator, would disqualify the subject from the study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Spirox, Inc.: lead
• New Arch Consulting: collaborator

Study Sites (11)

Sacramento ENT

Roseville, California, 95661, United States

Location

Breathe Clear Institute

Torrance, California, 90503, United States

Location

ENT of GA

Atlanta, Georgia, 30342, United States

Location

Chicago Nasal and Sinus Center

Chicago, Illinois, 60602, United States

Location

Michiana Sleep and ENT Solutions

South Bend, Indiana, 46635, United States

Location

Albany ENT & Allergy

Albany, New York, 12206, United States

Location

Piedmont ENT

Winston-Salem, North Carolina, 27103, United States

Location

Texas ENT Specialist

Houston, Texas, 77094, United States

Location

ENT Associates of Texas

McKinney, Texas, 78209, United States

Location

Texas Facial Plastics and ENT

San Antonio, Texas, 78239, United States

Location

Ogden Clinic

Ogden, Utah, 84403, United States

Location

Related Publications (1)

• Stolovitzky P, Senior B, Ow RA, Mehendale N, Bikhazi N, Sidle DM. Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial. Int Forum Allergy Rhinol. 2019 Aug;9(8):850-856. doi: 10.1002/alr.22362. Epub 2019 Jun 21.

  PMID: 31226238 RESULT

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Principal Clinical Research & Publications Manager
• Organization: Stryker ENT

ellen.omalley@stryker.com

763-463-1598

Study Officials

• Pablo Stolovitzky, MD

  ENT of Georgia

  PRINCIPAL INVESTIGATOR

• Douglas Sidle, MD

  Northwestern Facial Plastic Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be masked to treatment assignment through the 3-month assessment period.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sham procedure participants will be allowed to crossover to receive Latera implants after the 3-month assessment if they continue to meet eligibility criteria. Crossover participants will be followed through 24 months post implant. Sham participants who do not crossover will be exited after the 3-month assessment.

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 17, 2018
• Study Start: November 28, 2017
• Primary Completion: February 1, 2019
• Study Completion: December 23, 2020
• Last Updated: February 9, 2021
• Results First Posted: January 9, 2020

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)