## Protocol Section
### Identification Module
**NCT ID:** NCT06414083

**Brief Title:** Histologic Comparison of Ablative Techniques for Endometriosis

**Official Title:** Histologic Comparison of Ablative Techniques for Endometriosis - a Randomized Trial

#### Organization Study ID Info
**ID:** 24-007
#### Organization
**Class:** OTHER
**Full Name:** TriHealth Inc.
### Status Module
#### Completion Date
**Date:** 2025-06-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-28

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-05-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-09

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** TriHealth Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Endometriosis

- Endometriosis-related Pain

- Endometriosis Pelvic

- Endometriosis; Peritoneum

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Pathologist is blinded to treatment arm

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 141

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Device: Diathermy

**Label:** Diathermy

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Device: CO2 Laser

**Label:** CO2 Laser

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Intervention Names:**

- Device: Argon Beam Coagulator

**Label:** Argon Beam Coagulator

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Diathermy

**Description:** Diathermy will be used to ablate the randomized sample.

**Name:** Diathermy

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- CO2 Laser

**Description:** CO2 Laser will be used to ablate the randomized sample.

**Name:** CO2 Laser

**Type:** DEVICE

#### Intervention 3

**Arm Group Labels:**

- Argon Beam Coagulator

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

**Name:** Argon Beam Coagulator

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Endometriosis seen on pathologic sample.

**Measure:** Positive Histology

**Time Frame:** 0 days

#### Secondary Outcomes

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

**Measure:** Pelvic Pain

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** 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 Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** devin_namaky@trihealth.com

**Name:** Devin Namaky, MD

**Phone:** 513-862-1888

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Cincinnati

**Contacts:**

***Contact 1:***

- **Email:** devin_namaky@trihealth.com

- **Name:** Devin Namaky, MD

- **Phone:** 513-862-1888

- **Role:** CONTACT

**Country:** United States

**Facility:** Good Samaritan Hospital

**State:** Ohio

**Status:** RECRUITING

**Zip:** 45220

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M7877

- Name: Endometriosis

- Relevance: HIGH

- As Found: Endometriosis

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004715

- Term: Endometriosis

### Misc Info Module

- Version Holder: 2024-05-31
