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Barrigel spacer

Phase 1

Cervix Cancer | Unknown | Oncology |Teleflex Incorporated|Last Updated: Feb 4, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07292818Hyaluronic Acid-based Gel Spacers in Gynecologic MalignanciesPHASE1 RECRUITING 14Feb 2, 2026Oct 30, 2030Feb 4, 20261 United States
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Study Endpoints
Primary Endpoints
Safety based on Grade 3 or higher adverse events associated with hyaluronic acid-based rectal spacer placement
Up to 3 months after completion of radiotherapy

The NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) is a descriptive terminology that can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. Number of participants with Grade 3 or higher adverse events associated with hyaluronic acid-based rectal spacer placement will be presented.

Safety based on Patient Reported Outcome Report based on The Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment
Up to 3 months after completion of radiotherapy

Patient assessments of symptom characteristics will be surveyed based on the Patient Reported Outcome Report, based on the Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment. Each item in the EPIC bowel domain uses a 5-point Likert scale. The responses are numerically coded and then converted to a 0-100 scale, where higher scores = better function / less bother. No problem=1, very small problem =2, small problem=3, moderate problem=4, big problem=5

Safety based on Patient Reported Outcome Report based on Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Up to 3 months after completion of radiotherapy

The PRO-CTCAE survey, focused on gastrointestinal and genitourinary symptoms, will be used assessment of toxicity. The PRO-CTCAE Measurement System characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities reported from the patient perspective. PRO-CTCAE uses 5-point Likert scales to assess the frequency, severity, and daily life interference of patient-reported symptoms, with higher scores indicating more frequent, severe, or bothersome experiences.

Distance between uterus/cervix/proximal vagina and rectum
Up to 7 weeks (at the end of radiotherapy)

The distance between the uterus, cervix, proximal vagina, and rectum will be measured using images acquired during brachytherapy.

Gel placement procedure time
Up to 7 weeks (at the end of radiotherapy)

Time required to complete gel placement will be reported.

Difficulty of gel placement
Up to 7 weeks (at the end of radiotherapy)

Difficulty of Barrigel Procedure Insertion will be graded based on provider response to a 4-point scale survey. Higher scores represent difficult insertions. 1- Very Easy: All anatomical landmarks were easy to spot on transrectal ultrasonogram (TRUS), and Barrigel was well-visualized during injection. The tissue is separated well with Barrigel. Visible spacing between the cervix and rectum was achieved. The implant was positioned well and sculpted to the desired (symmetric) shape. 2- Easy: Most landmarks were easily seen, Barrigel was well-visualized, tissue separated reasonably well overall, although the shape may not be ideal. 3- Difficult: Some anatomy or Barrigel was difficult to visualize on TRUS, and/or the tissue didn't separate well in places with Barrigel. Spacing goals were notably not achieved, but some useful space was provided. 4- Very Difficult: The TRUS visibility was compromised, and/or the gel didn't get injected as planned due to tissue.

Secondary Endpoints
Implant geometry
Up to 7 weeks (at the end of radiotherapy)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeSUPPORTIVE_CARE
Treatment Arms
ArmTypeDescription
Brachytherapy with hyaluronic acid-based gel spacerEXPERIMENTALPatients with cervical cancer who are scheduled to undergo definitive chemoradiotherapy, including brachytherapy, with the use of hyaluronic acid-based gel spacer to increase the distance between the cervix and the anterior rectal wall.
Interventions
NameTypeDescription
Barrigel gel spacerDEVICEBarrigel (Hyaluronic acid- based gel spacer) will be used to increase the distance between the cervix and the anterior rectal wall, with the intent to decrease the radiation dose delivered to the rectum.
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. * Subject is willing and able to comply with study procedures based on the judgment of the investigator. * Age ≥ 18 years at time of consent. * Eas...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07292818studyFirstPostDate: changed