Histologic Comparison of Ablative Techniques for Endometriosis

NCT ID: NCT06414083

Last Updated: 2024-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-09

Study Completion Date

2025-06-09

Brief Summary

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To our knowledge, no other human studies directly compare the effectiveness of the various ablative technologies. We set out to design a study to directly compare ablative energy sources and evaluate their ability to destroy native endometriosis tissue in humans.

Detailed Description

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Conditions

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Endometriosis Endometriosis-related Pain Endometriosis Pelvic Endometriosis; Peritoneum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Pathologist is blinded to treatment arm

Study Groups

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Diathermy

Group Type ACTIVE_COMPARATOR

Diathermy

Intervention Type DEVICE

Diathermy will be used to ablate the randomized sample.

CO2 Laser

Group Type ACTIVE_COMPARATOR

CO2 Laser

Intervention Type DEVICE

CO2 Laser will be used to ablate the randomized sample.

Argon Beam Coagulator

Group Type ACTIVE_COMPARATOR

Argon Beam Coagulator

Intervention Type DEVICE

Argon Beam Coagulator will be used to ablate the randomized sample.

Interventions

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Diathermy

Diathermy will be used to ablate the randomized sample.

Intervention Type DEVICE

CO2 Laser

CO2 Laser will be used to ablate the randomized sample.

Intervention Type DEVICE

Argon Beam Coagulator

Argon Beam Coagulator will be used to ablate the randomized sample.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult women 18 years of age or older
* Already planning to undergo scheduled robotic assisted or laparoscopic excision of lesions for pelvic pain symptoms (pelvic pain, dysmenorrhea, dyspareunia, dysuria, dyschezia, ovarian pain) or endometriosis of any kind (endometriosis of any location, or endometrioma)

Exclusion Criteria

* Known pregnancy at enrollment or at the time of the excision surgery
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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TriHealth Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Good Samaritan Hospital

Cincinnati, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Devin Namaky, MD

Role: CONTACT

513-862-1888

Facility Contacts

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Devin Namaky, MD

Role: primary

513-862-1888

Other Identifiers

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24-007

Identifier Type: -

Identifier Source: org_study_id

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