A Novel Tapered Applicator for Vaginal Vault Brachytherapy

NCT04318340 | Completed DMC

• 1 other identifier: 2000026385
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the comfort and fit of a novel applicator for endometrial cancer patients who are candidates for vaginal brachytherapy. This study is only assessing the applicator fitting. No patients in this study will be treated with the novel applicator.

Conditions

Endometrial Cancer; Brachytherapy; Quality of Life

Outcome Measures

Primary Outcomes (2)

• Patient comfort

  Patient comfort will be assessed with a visual analog scale-based survey rating 0 (none) to 10 (severe) in each of the following domains: pain, pressure, burning, stress, hardness/roughness, and stretching at both insertion and in final resting positions.

  up to 10 minutes

• Ability to up-size with tapered applicator

  Determine what percentage of patients who would otherwise be treated with a standard 2.6cm diameter vaginal cylinder can be up-sized to a 3.0cm diameter cylinder with the novel tapered applicator design.

  up to 10 minutes

Secondary Outcomes (1)

• Assess in vivo dosimetry (optional for all patients)

  up to 10 minutes

Study Arms (2)

Standard Applicators

ACTIVE COMPARATOR

All patients will be fitted with the 2.6 cm applicator and sized up to the 3.0 cm applicator if tolerable.

Other: Standard applicator

Tapered Applicator

EXPERIMENTAL

All patients will be fitted with the novel tapered 3.0 cm applicator. Patients have the option of having magnetic resonance imaging with the tapered applicator in place.

Other: Tapered applicator

Interventions

Tapered applicator OTHER

An applicator inserted in 2 steps that tapers at the distal vagina

Tapered Applicator

Standard applicator OTHER

A 2.6 cm standard applicator is inserted and sized up to a standard 3 cm applicator if tolerable.

Standard Applicators

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Subjects meeting any of the criteria below may not participate in the study:
• Requires premedication with pain medications and/or anxiolytics during applicator fitting.
• Will receive pelvic EBRT.
• Prior known diagnosis of lupus, scleroderma, dermatomyositis, Crohn's disease, ulcerative colitis, pacemakers, or other contraindications to radiotherapy.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Smilow Cancer Hospital

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Shari Damast, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 23, 2020
• Study Start: July 16, 2020
• Primary Completion: March 20, 2023
• Study Completion: March 20, 2023
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)