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NCT Number: NCT06414083

Histologic Comparison of Ablative Techniques for Endometriosis

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.

Recruiting

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Key information

Conditions

Endometriosis Endometriosis Pelvic Endometriosis-related Pain Endometriosis; Peritoneum Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location status: Recruiting

Location contact

Devin Namaky, MD

CONTACT

[email protected]

513-862-1888

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diathermy

Device

Diathermy will be used to ablate the randomized sample.

CO2 laser

Device

CO2 Laser will be used to ablate the randomized sample.

Argon Beam Coagulator

Device

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

Primary outcomes

  1. Positive Histology

    Time frame: 0 days

    Endometriosis seen on pathologic sample.

Secondary outcomes

  1. Pelvic Pain

    Time frame: 3 months

    Pre-operative and Post-operative Pelvic Pain Visual Analog Scale. Minimum Score 0. Maximum Score 100. Higher score is worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Devin Namaky, MD

CONTACT

[email protected]

513-862-1888

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

Histologic Comparison of Ablative Techniques for Endometriosis - a Randomized Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 16, 2024
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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