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Clinical Trials/CTRI/2023/02/049831
CTRI/2023/02/049831CompletedPhase 4

A single centric non-randomized, post marketing surveillance study (PMS) to evaluate safety and tolerability of VELNEZ as a nasal pack as a nasal pack after nasal surgery in pediatric age-group.

Datt Mediproducts Pvt. Ltd.0 sites0 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 4
Status
Completed
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Pms

Eligibility Criteria

Inclusion Criteria

  • •1. Subject eligible for the use of VELNEZ as a nasal pack in routine clinical practice after a planned surgery (Either for septoplasty or turbinoplasty)
  • •2. Male and female children in the age group of 5 to 17 years. (Both Included)
  • •3. Subject’s parents (LAR Legally authorized representative) who can provide
  • •informed written consent i.e., Child Assent form.
  • •4. Subject’s parents (LAR) who are willing to provide their child study data to be
  • •collected at pre-defined follow-up period/ time and used for study objectives.

Exclusion Criteria

  • •1. Subject who are unable to be treated with the VELNEZ as a nasal packing in
  • •routine clinical practice after a planned surgery.
  • •2. Subject’s parents (LAR) who cannot provide informed written, Child Assent form
  • •for data collection.
  • •3. Subject found positive for HIV, HBsAg and HCV.
  • •4. Subject unwilling or unable to comply with the postoperative visits necessary for
  • •data collection.
  • •5. Subject with an active infection at the surgery site.
  • •6. Subject with a history of asthma.
  • •7. Subject who are on aspirin or anti-platelet drugs therapy and have bleeding
  • •8. Hypertensive subjects.
  • •9. Subjects who have a history of allergy (Hypersensitive) reactions with any of the
  • •ingredients of the device (VELNEZ) i.e., Chitosan, Gelatin and Psyllium husk etc.
  • •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).
  • •11. Subjects with severe rhinosinusitis involving all the paranasal sinuses associated
  • •with sinonasal polyposis, allergic fungal rhinosinusitis, gross septal deviation or
  • •spurs hitching on the ostiomeatal complex (OMC) region huge concha bullosa or
  • •allergic turbinate hypertrophy in contact with septum.
  • •12. Subject with a history of postoperative recurrent rhino sinusitis and subjects
  • •with bleeding diathesis.

Investigators

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