Nasal Septum; Deviation, CongenitalNCT05243147

Design and Application of Nasal Stents

A study testing nasal stents and merocel in people with Nasal Septum; Deviation, Congenital, run by Peking University Third Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Comparative study of nasal stents and nasal packing in patients undergoing septoplasty Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Nasal Septum; Deviation, Congenital
What is being tested?: nasal stents and merocel
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteChina
Study dates: 22 Oct 2020to 30 Aug 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The subjects voluntarily participate in the experiment and sign the informed consent;
Age range from 18 to 70 years old, gender unlimited;
With nasal congestion as the chief complaint, CT of sinus suggested deviation of nasal septum with indications of surgery (deviation of nasal septum affects breathing and nasal congestion is serious; High nasal septum deviation affects sinus drainage or causes reflex headache; Nasal septum spine often causes nasal bleeding; Nasal septum deviation affects eustachian tube function);
No history of respiratory tract infection and nasal decongestant use within 1 month before the visit;
No other treatment was used;
ASA grade 1~2;
Able to communicate well with researchers and follow the requirements of the experiment.

Who cannot join

There are acute and chronic rhinosinusitis, nasal polyps, benign and malignant tumors and other nasal diseases;
History of craniocerebral and nasal surgery;
The results of preoperative coagulation function test exceeded 20% of the upper limit of normal value;
Patients known to be allergic to test instrument materials;
Pregnant or lactating women;
Other organoplastic or functional diseases complicated by the subjects limited their participation in the study and could not comply with the follow-up or affect the scientific integrity of the study;
Participants who have participated in other clinical trials within the last 1 month;
Participants considered unsuitable for this clinical trial for other reasons.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University Third Hospital
Beijing, Beijing Municipality, 100191

Other trials in China

About this study

Official title: Clinical Control Study of Application of Nasal Stent and Merocel Sponge After Nasal Septoplasty

Comparative study of nasal stents and nasal packing in patients undergoing septoplasty

Read the detailed description

To investigate the safety and effectiveness of nasal stent in clinical application by comparing and observing the clinical effect and comfort of nasal stent and merocel sponge applied in nasal septoplasty. Methods: patients with nasal septal deviation were selected and randomly divided into nasal stent group (experimental group) and merocel sponge group (control group) according to the packing method. The hemostasis effect, comfort and complications of the two groups were compared during the packing period.

Conditions: Nasal Septum; Deviation, Congenital
Being tested: nasal stents, merocel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

nasal stentsDevice
using nasal stents after septoplasty
merocelDevice
using merocel after septoplasty

Study groups in NCT05243147
Study group	Role	What they receive
nasal stents	Experimental	using nasal stents after septoplasty Receives: Device: nasal stents
merocel	Other	using merocel as nasal packing after septoplasty Receives: Device: merocel

What is being measured

The primary outcome is the main question the study is designed to answer.

Effective rate of packing
(1) In the period of nasal tamponade and after the removal of the tamponade instrument (48 h ± 1 h after surgery), the nasal bleeding score was ≤ 2 points; (2) 48 h ± 1 h after the completion of nasal tamponade, the overall discomfort score ≤ 7 points; (3) No septal hematoma and nasal adhesions were confirmed by nasal endoscopy at 30 days ± 5 days after the operation. Nasal tamponade is considered effective when the above 3 criteria are met.
Measured: 2days after operation

Secondary outcomes (2)

visual analog scale（VAS）of comfort
including nasal congestion, nasal pain, headache, itchy nose sneezing, watery tears, runny nose, nasal reflux, facial swelling, difficulty swallowing, sleep disturbance, dry mouth, and general discomfort. The severity of each symptom was graded using the visual analog scale (VAS) of 0 (none) to10 (unbearable)
Measured: 2days after operation
security
The incidence of complications and adverse events were used as safety evaluation indexes
Measured: 30days after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Oct 202030 Aug 2022

First posted16 Feb 2022
Study start22 Oct 2020
Primary completion30 Aug 2022
Study completion30 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Nasal Septum; Deviation, CongenitalStudies of the same condition, open and under way.
More trials run by Peking University Third HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05243147
Sponsor's protocol ID: PUTH-NS
Status last verified: Dec 2022
First submitted: 28 Dec 2021
Last updated: 31 May 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Control Study of Application of Nasal Stent and Merocel Sponge After Nasal Septoplasty
ClinicalTrials.gov ID: NCT05243147
Acronym / sponsor ID: PUTH-NS
Conditions: Nasal Septum; Deviation, Congenital
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Peking University Third HospitalUniversity, hospital or other
Study start: 22 Oct 2020 (actual)
Primary completion: 30 Aug 2022 (actual)
Study completion: 30 Aug 2022 (actual)
First posted: 16 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Comparative study of nasal stents and nasal packing in patients undergoing septoplasty

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
nasal stents	Experimental	Device: nasal stentsusing nasal stents after septoplasty
merocel	Other	Device: merocelusing merocel as nasal packing after septoplasty

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

The subjects voluntarily participate in the experiment and sign the informed consent;
Age range from 18 to 70 years old, gender unlimited;
With nasal congestion as the chief complaint, CT of sinus suggested deviation of nasal septum with indications of surgery (deviation of nasal septum affects breathing and nasal congestion is serious; High nasal septum deviation affects sinus drainage or causes reflex headache; Nasal septum spine often causes nasal bleeding; Nasal septum deviation affects eustachian tube function);
No history of respiratory tract infection and nasal decongestant use within 1 month before the visit;
No other treatment was used;

Key exclusion criteria (8 listed)

There are acute and chronic rhinosinusitis, nasal polyps, benign and malignant tumors and other nasal diseases;
History of craniocerebral and nasal surgery;
The results of preoperative coagulation function test exceeded 20% of the upper limit of normal value;
Patients known to be allergic to test instrument materials;
Pregnant or lactating women;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
nasal stentsusing nasal stents after septoplasty	Device	nasal stents
merocelusing merocel after septoplasty	Device	merocel

Primary outcome

Effective rate of packing
Time frame: 2days after operation
(1) In the period of nasal tamponade and after the removal of the tamponade instrument (48 h ± 1 h after surgery), the nasal bleeding score was ≤ 2 points; (2) 48 h ± 1 h after the completion of nasal tamponade, the overall discomfort score ≤ 7 points; (3) No septal hematoma and nasal adhesions were confirmed by nasal endoscopy at 30 days ± 5 days after the operation. Nasal tamponade is considered effective when the above 3 criteria are met.

2 secondary outcomes

visual analog scale（VAS）of comfort
Time frame: 2days after operation
security
Time frame: 30days after operation

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Junxiu Liu principal investigator

Peking University Third Hosptial

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing nasal stents and merocel in people with Nasal Septum; Deviation, Congenital, run by Peking University Third Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effective rate of packing (time frame: 2days after operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05243147.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.