Safety and Performance of ENTACT Septal Staple System for Septoplasty

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-22

Study Completion Date

2021-06-25

Brief Summary

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This is a prospective, multi-center, single arm PMCF study to evaluate the safety and performance of the ENTACT (Next Generation) resorbable staple system for septoplasty in 40 subjects. The study purpose is to provide evidence to satisfy the PMCF requirements of CE Marking to market this device in Europe (data may be used to support registrations on other countries as well).

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Detailed Description

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The primary objective of this study is to demonstrate clinical success of the ENTACT (Next Generation) resorbable septal staple system by examining the patient's nasal cavity at the 21 day follow-up visit.

The secondary objectives are to generate performance and health economics data to support the use of ENTACT (Next Generation) resorbable septal staple.

Conditions

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Septoplasty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Device: ENTACT Septal Staple

Septoplasty

ENTACT Septal Staple system

Intervention Type DEVICE

The ENTACT Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue during nasal septal surgery.

Interventions

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ENTACT Septal Staple system

The ENTACT Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue during nasal septal surgery.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Able and willing to give informed consent by voluntarily providing written informed consent in accordance with governing Institutional Review Board (IRB);
2. Clinically significant deviation of the nasal septum;
3. Willing and able to make all required study visits;
4. Able to read and understand the approved informed consent form and patient reported outcome assessments (written and oral)

Exclusion Criteria

1. Prolonged tissue approximation beyond that needed for normal tissue closure is necessary or desired;
2. Traditional suturing techniques are necessary;
3. Radiopacity is necessary or desired since ENTACT septal staples are radiotransparent;
4. Known to be allergic to foreign body of materials of investigational product;
5. Concomitant procedures other than turbinectomy, turbinate reduction, and/or sinus surgery;
6. Pregnancy at time of procedure;
7. Presence of infection at the site;
8. Severe drug and alcohol abusers;
9. Autoimmune disease deemed clinically significant by Principal Investigator (PI).

Eligible Sex

ALL

Accepts Healthy Volunteers

No