Clinical Feasibility of the ARCHITECT Applicator in Cervical Cancer Brachytherapy

Sponsor
Erasmus Medical Center
Study ID
NCT07435987
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ARCHITECT applicator — DEVICE
    Patient-tailored, 3D-printed applicator

Study Details

This prospective, non-randomised, single centre, phase I trial assesses the clinical feasibility of the use of the patient-tailored ARCHITECT applicator in locally advanced cervical cancer brachytherapy.

Key Dates

Start date
May 31, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Study arm
    In general in Erasmus Medical Centre, two applications are applied with an interval of one week for the HDR IGABT. Patients will be treated with a commercially available applicator (conform the current clinical practice) at week 1 and with the patient-tailored ARCHITECT applicator (study intervention) at week 2.

Primary Outcome Measure

Clinical feasibility [ Time Frame: At week 2 (ARCHITECT applicator) ]

Central Contacts

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