Skip to main content
MedPathMedPath Home
Clinical Trials/CTRI/2018/04/013227
CTRI/2018/04/013227
Completed
Phase 4

A post marketing surveillance study (PMS) to evaluate safety and tolerability of VELNEZ as a nasal pack after nasal surgery

Datt Mediproducts Pvt Ltd0 sites37 target enrollmentTBD
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsHealth Condition 1: null- All patients who will meet the study related inclusion & exclusion criteria and eligible to use VELNEZ as a nasal pack in routine clinical practice after planned nasal surgeryHealth Condition 2: O- Medical and SurgicalHealth Condition 3: O- Medical and Surgical

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: null- All patients who will meet the study related inclusion & exclusion criteria and eligible to use VELNEZ as a nasal pack in routine clinical practice after planned nasal surgeryHealth Condition 2: O- Medical and SurgicalHealth Condition 3: O- Medical and Surgical
Sponsor
Datt Mediproducts Pvt Ltd
Enrollment
37
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
May 18, 2020
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Subject eligible to use VELNEZ as a nasal pack in routine clinical practice after planned surgery (either for septoplasty, turbinoplasty).
  • •2\.Male and female of age group between 18 to 60 years.
  • •3\.Subjects who can provide informed consent form in writing to provide data for the study.
  • •4\.Subjects who allow their data to be collected for the study at predefined follow\-upperiods.

Exclusion Criteria

  • •1\.Subject whose nasal cavity cannot be packed with the VELNEZ as a nasal pack in routine clinical practice after planned surgery.
  • •2\.Subjects who cannot provide written informed consent for data collection.
  • •3\.Subjects unwilling or unable to comply with the postoperative visits necessary for data collection.
  • •4\.Subject with an active infection at the planned surgery site.
  • •5\.Subjects who have a history of asthma
  • •6\.Subjects who are on aspirin or anti\-platelet drugs therapy.
  • •7\.Hypertensive subjects
  • •8\.Subjects who have a history of allergic (Hypersensitive) reactions with any of the ingredients of the device i.e Chitosan, Gelatin and Psyllium husk etc.
  • •9\.Subjects who have bleeding disorders.
  • •10\.Any medical condition that, in the opinion of the investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study).

Outcomes

Primary Outcomes

Not specified

Similar Trials

Completed
Phase 4
A study to assess the safety and tolerability of VELNEZ nasal pack after surgery of noseHealth Condition 1: O- Medical and Surgical
CTRI/2018/12/016535Datt Mediproducts Pvt Ltd40
Completed
Phase 4
A study (PMS) to check and assess the safety and tolerability of a biodegradable nasal dressing (VELNEZ) after nose surgery.Health Condition 1: J348- Other specified disorders of noseand nasal sinuses
CTRI/2021/09/036437Datt Mediproducts Pvt Ltd20
Active, not recruiting
Phase 1
Study To Evaluate The Safety And Efficacy Of Vfend® IV in Korean patients
EUCTR2017-000197-11-Outside-EU/EEAPfizer Inc.400
Active, not recruiting
Phase 4
A prospective, Post Marketing Surveillance study of omalizumab in Chronic Spontaneous UrticariaHealth Condition 1: null- Xolair in CS
CTRI/2015/10/006247ovartis Healthcare Private Limited
Not yet recruiting
Phase 4
Post marketing surveillance study of Pitavastatin for evaluation of its safety and efficacy in patients with diabetes and high cholesterolHealth Condition 1: null- Diabetic Dyslipidemia
CTRI/2013/05/003686Cadila Healthcare500