NCT07332585

Brief Summary

The prelacrimal recess approach is a minimally invasive approach to maxillary sinus lesions. The current study aimed to evaluate the efficacy of piezosurgery versus conventional osteotomy while performing a prelacrimal apporach.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 30, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
Last Updated

January 12, 2026

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

December 30, 2025

Last Update Submit

December 30, 2025

Conditions

Maxillary Sinus Disease

Outcome Measures

Primary Outcomes (2)

  • Intraoperative bleeding

    The amount of blood collected in the suction device

    During the surgical procedure

  • Operative time

    the time of surgical procedure

    During the surgical procedure

Secondary Outcomes (1)

  • Postoperative hyposthesia

    six months after surgery

Study Arms (2)

piezosurgery group

ACTIVE COMPARATOR
Procedure: piezo-assisted prelacrimal apporach

conventional osteotomy group

ACTIVE COMPARATOR
Procedure: conventional osteotomy prelacrimal approach

Interventions

piezo-assisted prelacrimal apporachPROCEDURE

The removal of the bone in the prelacrimal approach was done using piezo ultrasonic device

piezosurgery group
conventional osteotomy prelacrimal approachPROCEDURE

The removal of the bone in the prelacrimal approach was done using conventional osteotome and hammer

conventional osteotomy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any maxillary sinus pathology (recurrent Antrochoanal polyp, inverted papilloma, fungal ball, allergic fungal sinusitis, CRSwNP, CRSeNP, orbital floor fracture, etc).
  • Favorable prelacrimal recess (Type II or III Simmen classification)
  • Age\> 18 years.
  • No gender limitation.

You may not qualify if:

  • patients with malignant sino-nasal tumors.
  • patients unfit for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Mansoura University

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2025

First Posted

January 12, 2026

Study Start

December 1, 2024

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

January 12, 2026

Record last verified: 2025-12

Locations

EG(1)